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A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-01-10
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
This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
SativexContains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 45 | -0.6 | 1.13 |
| GW-2000-02 | 47 | -0.6 | 1.34 |
| Placebo | 47 | 0.0 | 1.23 |
Eligibility
primary outcomes
Time frame: Up to 74 days
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
secondary outcomes
Time frame: Up to 74 days
Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as "None", "Once", "Twice" and "More Than Twice" and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero "Worst Imaginable" to 10 "Best Imaginable". The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.
Time frame: Up to 74 days
Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = "None", one = "Mild", two = "Moderate" and three = "Severe". The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.
Time frame: Up to 74 days
Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero "No pain" to 100 "Worst possible pain". Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Publications
No exact PMID-linked public article is currently readable locally.
Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as "None", "Once", "Twice" and "More Than Twice" and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 44 | -0.2 | 0.43 |
| GW-2000-02 | 46 | -0.4 | 0.51 |
| Placebo | 46 | 0.0 | 0.47 |
Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero "Worst Imaginable" to 10 "Best Imaginable". The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 45 | 0.9 | 1.22 |
| GW-2000-02 | 47 | 1.2 | 1.39 |
| Placebo | 47 | 0.4 | 1.40 |
Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = "None", one = "Mild", two = "Moderate" and three = "Severe". The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | -3.2 | 8.91 |
| GW-2000-02 | 46 | -3.8 | 9.37 |
| Placebo | 48 | -1.8 | 9.26 |
Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero "No pain" to 100 "Worst possible pain". Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | -14.9 | 25.15 |
| GW-2000-02 | 47 | -17.3 | 26.74 |
| Placebo | 48 | -8.0 | 26.92 |
Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as "No Pain", "Mild", "Discomforting", "Distressing", "Horrible" and "Excruciating". The change from baseline in the number of patients who reported "No Pain" or "Mild Pain" at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | 4 | - |
| GW-2000-02 | 47 | 4 | - |
| Placebo | 48 | 3 | - |
The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with "no disability" and 10 equated with "total disability". The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | -5.3 | 9.97 |
| GW-2000-02 | 47 | -3.1 | 10.37 |
| Placebo | 48 | -3.6 | 7.69 |
The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | -2.2 | 6.70 |
| GW-2000-02 | 47 | -1.2 | 6.12 |
| Placebo | 48 | 0.1 | 3.92 |
The number of patients who experienced an adverse event during the course of study is presented.
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 46 | 34 | - |
| GW-2000-02 | 47 | 37 | - |
| Placebo | 48 | 20 | - |
| Milestone | GW-1000-02 First, Then GW-2000-02, Then Placebo | GW-2000-02 First, Then GW-1000-02, Then Placebo | Placebo First, Then GW-1000-02, Then GW-2000-02 | GW-1000-02 First, Then Placebo, Then GW-2000-02 | Placebo First, Then GW-2000-02, Then GW-1000-02 | GW-2000-02 First, Then Placebo, Then GW-1000-02 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 8 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | GW-1000-02 First, Then GW-2000-02, Then Placebo | GW-2000-02 First, Then GW-1000-02, Then Placebo | Placebo First, Then GW-1000-02, Then GW-2000-02 | GW-1000-02 First, Then Placebo, Then GW-2000-02 | Placebo First, Then GW-2000-02, Then GW-1000-02 | GW-2000-02 First, Then Placebo, Then GW-1000-02 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 8 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | GW-1000-02 First, Then GW-2000-02, Then Placebo | GW-2000-02 First, Then GW-1000-02, Then Placebo | Placebo First, Then GW-1000-02, Then GW-2000-02 | GW-1000-02 First, Then Placebo, Then GW-2000-02 | Placebo First, Then GW-2000-02, Then GW-1000-02 | GW-2000-02 First, Then Placebo, Then GW-1000-02 |
|---|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 | 7 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | GW-1000-02: 1 / 46 · GW-2000-02: 0 / 47 · Placebo: 0 / 48 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dizziness | Nervous system disorders | GW-1000-02: 9 / 46 · GW-2000-02: 11 / 47 · Placebo: 4 / 48 |
| Somnolence | Nervous system disorders | GW-1000-02: 7 / 46 · GW-2000-02: 6 / 47 · Placebo: 5 / 48 |
| Dysgeusia | Nervous system disorders | GW-1000-02: 10 / 46 · GW-2000-02: 5 / 47 · Placebo: 0 / 48 |
| Headache Not Otherwise Specified | Nervous system disorders | GW-1000-02: 0 / 46 · GW-2000-02: 5 / 47 · Placebo: 0 / 48 |
| Nausea | Gastrointestinal disorders | GW-1000-02: 0 / 46 · GW-2000-02: 5 / 47 · Placebo: 3 / 48 |
| Dry Mouth | Nervous system disorders | GW-1000-02: 3 / 46 · GW-2000-02: 3 / 47 · Placebo: 0 / 48 |
| Oral Discomfort | Gastrointestinal disorders | GW-1000-02: 0 / 46 · GW-2000-02: 0 / 47 · Placebo: 4 / 48 |
| Feeling Drunk | General disorders | GW-1000-02: 4 / 46 · GW-2000-02: 4 / 47 · Placebo: 0 / 48 |
| Lethargy | General disorders | GW-1000-02: 0 / 46 · GW-2000-02: 3 / 47 · Placebo: 0 / 48 |
| Pain Exacerbated | General disorders | GW-1000-02: 0 / 46 · GW-2000-02: 4 / 47 · Placebo: 0 / 48 |
| Thirst | General disorders | GW-1000-02: 0 / 46 · GW-2000-02: 3 / 47 · Placebo: 0 / 48 |
| Euphoric Mood | Psychiatric disorders | GW-1000-02: 3 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | GW-1000-02: 2 / 46 · GW-2000-02: 4 / 47 · Placebo: 0 / 48 |
| Dysarthria | Nervous system disorders | GW-1000-02: 0 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
| Paresthesia Oral | Nervous system disorders | GW-1000-02: 0 / 46 · GW-2000-02: 2 / 47 · Placebo: 2 / 48 |
| Hypoaesthesia | Nervous system disorders | GW-1000-02: 2 / 46 · GW-2000-02: 0 / 47 · Placebo: 0 / 48 |
| Oral Pain | Gastrointestinal disorders | GW-1000-02: 2 / 46 · GW-2000-02: 2 / 47 · Placebo: 2 / 48 |
| Dyspepsia | Gastrointestinal disorders | GW-1000-02: 0 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
| Hypoaesthesia Oral | Gastrointestinal disorders | GW-1000-02: 0 / 46 · GW-2000-02: 0 / 47 · Placebo: 2 / 48 |
| Fatigue | General disorders | GW-1000-02: 0 / 46 · GW-2000-02: 0 / 47 · Placebo: 2 / 48 |
| Irritability | Psychiatric disorders | GW-1000-02: 0 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
| Panic Attack | Psychiatric disorders | GW-1000-02: 0 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
| Appetite Increased | Metabolism and nutrition disorders | GW-1000-02: 2 / 46 · GW-2000-02: 2 / 47 · Placebo: 0 / 48 |
Time frame: Up to 74 days
Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as "No Pain", "Mild", "Discomforting", "Distressing", "Horrible" and "Excruciating". The change from baseline in the number of patients who reported "No Pain" or "Mild Pain" at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.
Time frame: Up to 74 days
The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with "no disability" and 10 equated with "total disability". The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.
Time frame: Up to 114 days
The number of patients who experienced an adverse event during the course of study is presented.