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The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2016-11-21
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)
ALO-02Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 343 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 207 | - |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Eligibility
primary outcomes
Time frame: Baseline up to end of study (2 weeks post-end of month 12)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
secondary outcomes
Time frame: Baseline up to end of study (2 weeks post-end of month 12)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to Month 12
The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.
Time frame: Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.
other outcomes
Time frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Time frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Noroxycodone was a metabolite of Oxycodone.
Time frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Time frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
6-Beta-naltrexol was a metabolite of naltrexone.
Time frame: Baseline up to Month 12
Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (\>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.
Time frame: Baseline up to 2 weeks after last dose
Duration of exposure to study medication during the course of the study was assessed.
Time frame: Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
Time frame: Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.
Publications
No exact PMID-linked public article is currently readable locally.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 94 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 202 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 47 | - |
The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 13.2 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 0.0 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 0.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 0.0 | - |
The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 5.4 | 5.49 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 4.6 | 6.15 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.6 | 4.32 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.6 | 4.70 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.3 | 4.53 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.9 | 4.30 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.2 | 4.56 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.5 | 3.27 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.4 | 4.07 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.5 | 3.74 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.4 | 4.08 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.2 | 3.25 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.3 | 3.53 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.4 | 4.09 |
Population: Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Noroxycodone was a metabolite of Oxycodone.
Population: Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Population: Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
6-Beta-naltrexol was a metabolite of naltrexone.
Population: Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (\>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 246 | 11.0 | 3 to 133 |
Duration of exposure to study medication during the course of the study was assessed.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 171.0 | 1 to 406 |
Population: Safety analysis set. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 38.6 | 81.27 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 51.7 | 35.53 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 62.8 | 42.65 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 66.1 | 40.35 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 68.0 | 40.36 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 68.6 | 41.49 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 71.5 | 43.58 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 73.1 | 43.22 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 76.7 | 43.76 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 77.7 | 45.67 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 76.5 | 44.58 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 77.9 | 44.45 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 76.2 | 43.14 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 26.9 | 22.79 |
Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.
Population: Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 256 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 204 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 167 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 124 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 120 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 112 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 104 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 96 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 96 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 93 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 79 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 80 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 85 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 30 | - |
Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.
Population: Safety analysis set. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 86.8 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 41.7 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 43.0 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 43.2 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 39.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 41.4 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 44.2 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 41.8 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 44.1 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 44.8 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 44.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 50.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 57.1 | - |
The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.
Population: Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 21.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 8.9 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 10.0 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 8.3 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 6.7 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 5.1 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 2.6 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.2 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 5.0 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 5.7 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 4.8 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 3.7 | - |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 395 | 15.3 | - |
Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.
Population: Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.
Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question "Please rate your overall satisfaction with the study drug you received?" where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied.
Population: ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 3.3 | 1.03 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 3.8 | 0.99 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 3.9 | 0.94 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.1 | 0.88 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.1 | 0.93 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 0.90 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 0.89 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 0.81 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 0.81 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 0.96 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.3 | 0.73 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.3 | 0.79 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 4.2 | 1.04 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 3.6 | 1.27 |
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain right now" was reported.
Population: ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 5.6 | 2.17 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -0.6 | 2.16 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.3 | 2.29 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.6 | 2.36 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.34 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.29 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.29 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.38 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.40 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.48 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.39 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.41 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.31 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.44 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.4 | 2.58 |
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours" was reported.
Population: ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 5.9 | 1.74 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -0.6 | 1.64 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.2 | 1.95 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.5 | 2.11 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.12 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.04 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.02 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.11 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.17 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.12 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.21 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.7 | 2.26 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.02 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.23 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.3 | 2.32 |
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain at its worst in the last 24 hours" was reported.
Population: ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | 7.4 | 1.63 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -0.7 | 1.96 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.3 | 2.24 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.6 | 2.39 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.8 | 2.32 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.12 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.9 | 2.41 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.0 | 2.30 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.0 | 2.43 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.0 | 2.31 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.2 | 2.48 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.1 | 2.50 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.2 | 2.41 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -2.2 | 2.44 |
| Oxycodone Hydrochloride (HCl) and Naltrexone HCl | 387 | -1.6 | 2.52 |
| Milestone | Oxycodone Hydrochloride (HCl) and Naltrexone HCl |
|---|---|
| STARTED | 395 |
| COMPLETED | 158 |
| NOT COMPLETED | 237 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Hypochromic anaemia | Blood and lymphatic system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Acute myocardial infarction | Cardiac disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 2 / 395 |
| Cardiac failure congestive | Cardiac disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Abdominal pain | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Hiatus hernia | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Pancreatitis acute | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Small intestinal obstruction | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Chest discomfort | General disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Chest pain | General disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Non-cardiac chest pain | General disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 2 / 395 |
| Cholecystitis | Hepatobiliary disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Cholelithiasis | Hepatobiliary disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Infected skin ulcer | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Osteomyelitis | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Pneumonia | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 2 / 395 |
| Urinary tract infection | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Blood pressure increased | Investigations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Hypoglycaemia | Metabolism and nutrition disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Cerebrovascular accident | Nervous system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Convulsion | Nervous system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 2 / 395 |
| Mental status changes | Psychiatric disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Nephrolithiasis | Renal and urinary disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 2 / 395 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 1 / 395 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 100 / 395 |
| Constipation | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 84 / 395 |
| Vomiting | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 55 / 395 |
| Diarrhoea | Gastrointestinal disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 36 / 395 |
| Fatigue | General disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 36 / 395 |
| Upper respiratory tract infection | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 24 / 395 |
| Influenza | Infections and infestations | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 20 / 395 |
| Back pain | Musculoskeletal and connective tissue disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 25 / 395 |
| Headache | Nervous system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 46 / 395 |
| Somnolence | Nervous system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 37 / 395 |
| Dizziness | Nervous system disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 34 / 395 |
| Anxiety | Psychiatric disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 30 / 395 |
| Insomnia | Psychiatric disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 20 / 395 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 24 / 395 |
| Pruritus | Skin and subcutaneous tissue disorders | Oxycodone Hydrochloride (HCl) and Naltrexone HCl: 21 / 395 |
Time frame: Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.
Time frame: Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.
Time frame: Up to Week 4
Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.
Time frame: Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment
Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question "Please rate your overall satisfaction with the study drug you received?" where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied.
Time frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain right now" was reported.
Time frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours" was reported.
Time frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain at its worst in the last 24 hours" was reported.