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The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-05-03
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 is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
GW-4000-01Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
GW-1000-02Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
GW-2000-02 · THCSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 53 | -1.32 | -1.44 to -0.14 |
| THC Alone | 52 | -0.93 | -1.02 to 0.19 |
| Placebo | 56 | -0.73 | 1.51 |
Eligibility
primary outcomes
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Subjects recorded their use of escape medication each day on their diary card.
secondary outcomes
Time frame: 2 weeks: baseline to end of week 2 (last 3 days of treatment)
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time frame: 2 weeks; baseline - end of week 2 (last 3 days of treatment)
The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Time frame: 2 weeks; baseline and end of treatment (2 weeks)
Publications
No exact PMID-linked public article is currently readable locally.
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | -0.59 | -0.97 to 0.34 |
| THC Alone | 54 | -0.25 | -0.64 to 0.68 |
| Placebo | 56 | -0.21 | 1.72 |
The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | 0 | -0.11 to 1.09 |
| THC Alone | 54 | 0.27 | -0.13 to 1.05 |
| Placebo | 56 | -0.16 | 1.25 |
The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | 0.58 | 2.06 |
| THC Alone | 54 | 0.57 | 1.90 |
| Placebo | 56 | 0 | 1.35 |
The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | 0.24 | 2.29 |
| THC Alone | 54 | 0.18 | 1.91 |
| Placebo | 56 | -1.65 | 1.94 |
The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | 0.26 | 1.66 |
| THC Alone | 54 | 0.22 | 1.80 |
| Placebo | 56 | -0.32 | 1.39 |
Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 49 | 4.93 | 17.51 |
| THC Alone | 50 | 3.57 | 18.32 |
| Placebo | 52 | 4.74 | 18.50 |
The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 15 | 0.2 | 5.63 |
| THC Alone | 17 | -3.38 | 6.43 |
| Placebo | 18 | 0.41 | 5.55 |
Subjects recorded their use of escape medication each day on their diary card.
Population: The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 54 | 0.72 | -0.25 to 0.16 |
| THC Alone | 52 | 0.88 | -0.19 to 0.22 |
| Placebo | 57 | 0.68 | 0.662 |
| Milestone | Sativex | THC Alone | Placebo |
|---|---|---|---|
| STARTED | 60 | 58 | 59 |
| COMPLETED | 48 | 45 | 51 |
| NOT COMPLETED | 12 | 13 | 8 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 2 / 59 |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Nausea | Gastrointestinal disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Nausea aggravated | Gastrointestinal disorders | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Disease progression nos | General disorders | Sativex: 1 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Chest pain | General disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Malaise | General disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Weakness | General disorders | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Bronchopneumonia nos | Infections and infestations | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Oral candidiasis | Infections and infestations | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Blood urine present | Investigations | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Hyperglycaemia nos | Metabolism and nutrition disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Back pain | Musculoskeletal and connective tissue disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Chest wall pain | Musculoskeletal and connective tissue disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Groin pain | Musculoskeletal and connective tissue disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Neoplasm progression nos | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 6 / 60 · THC Alone: 5 / 58 · Placebo: 2 / 59 |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 2 / 59 |
| Metastases to brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 0 / 60 · THC Alone: 2 / 58 · Placebo: 0 / 59 |
| Metastases to prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Somnolence | Nervous system disorders | Sativex: 1 / 60 · THC Alone: 2 / 58 · Placebo: 1 / 59 |
| Cerebrovascular accident | Nervous system disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Spinal cord compression nos | Nervous system disorders | Sativex: 1 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Syncope | Nervous system disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Tremor | Nervous system disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Confusion | Psychiatric disorders | Sativex: 0 / 60 · THC Alone: 2 / 58 · Placebo: 1 / 59 |
| Anxiety | Psychiatric disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Disorientation | Psychiatric disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Urinary retention | Renal and urinary disorders | Sativex: 2 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Renal Failure nos | Renal and urinary disorders | Sativex: 0 / 60 · THC Alone: 1 / 58 · Placebo: 0 / 59 |
| Dyspnoea nos | Respiratory, thoracic and mediastinal disorders | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Family stress nos | Social circumstances | Sativex: 0 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Somnolence | Nervous system disorders | Sativex: 9 / 60 · THC Alone: 8 / 58 · Placebo: 8 / 59 |
| Nausea | Gastrointestinal disorders | Sativex: 7 / 60 · THC Alone: 6 / 58 · Placebo: 6 / 59 |
| Dizziness | Nervous system disorders | Sativex: 7 / 60 · THC Alone: 7 / 58 · Placebo: 3 / 59 |
| Neoplasm progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 6 / 60 · THC Alone: 5 / 58 · Placebo: 3 / 59 |
| Vomiting | Gastrointestinal disorders | Sativex: 5 / 60 · THC Alone: 4 / 58 · Placebo: 4 / 59 |
| Confusion | Psychiatric disorders | Sativex: 4 / 60 · THC Alone: 0 / 58 · Placebo: 2 / 59 |
| Diarrhoea NOS | Gastrointestinal disorders | Sativex: 4 / 60 · THC Alone: 0 / 58 · Placebo: 2 / 59 |
| Constipation | Gastrointestinal disorders | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 6 / 59 |
| Liver function test NOS abnormal | Investigations | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 2 / 59 |
| Weakness | General disorders | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Vertigo | Ear and labyrinth disorders | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 1 / 59 |
| Hypotension NOS | Vascular disorders | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Urinary retention | Renal and urinary disorders | Sativex: 3 / 60 · THC Alone: 0 / 58 · Placebo: 0 / 59 |
| Oral pain | General disorders | Sativex: 0 / 60 · THC Alone: 5 / 58 · Placebo: 3 / 59 |
| Glossodynia | General disorders | Sativex: 0 / 60 · THC Alone: 5 / 58 · Placebo: 0 / 59 |
| Gamma-glutamyltransferase increased | Investigations | Sativex: 0 / 60 · THC Alone: 5 / 58 · Placebo: 3 / 59 |
| Fatigue | General disorders | Sativex: 0 / 60 · THC Alone: 3 / 58 · Placebo: 0 / 59 |
| Chest Pain | General disorders | Sativex: 0 / 60 · THC Alone: 3 / 58 · Placebo: 1 / 59 |
Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Time frame: End of 2 weeks
The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.