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The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.
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 ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 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:CBD 120 mg) in 24 hours
GW-10000-02containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.
GW-4001-01Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 60 | -1.08 | 1.42 |
| Placebo | 64 | -0.99 | 1.09 |
Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Eligibility
primary outcomes
Time frame: 0 - 10 weeks
To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
secondary outcomes
Time frame: Daily diary entries throughout 10 week study period
Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time frame: 0 - 10 weeks
Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time frame: 0 - 10 weeks
Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time frame: 0 - 10 weeks
The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.
Publications
No exact PMID-linked public article is currently readable locally.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 60 | -1.91 | 2.44 |
| Placebo | 64 | -1.12 | 2.80 |
Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 60 | -0.55 | 0.75 |
| Placebo | 64 | -0.21 | 0.70 |
Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 48 | -0.88 | 1.50 |
| Placebo | 55 | -0.73 | 1.64 |
The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 59 | 14.21 | 17.51 |
| Placebo | 61 | 9.58 | 12.77 |
Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = "no problems" and 10 = "intolerable problems". Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 61 | -2.3 | 2.16 |
| Placebo | 66 | -0.9 | 2.04 |
Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The numbers who scored 1, 2, or 3 are presented.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 63 | 51 | - |
| Placebo | 67 | 39 | - |
Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Population: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 60 | -1.73 | 1.95 |
| Placebo | 64 | -0.87 | 1.86 |
| Milestone | Sativex | Placebo |
|---|---|---|
| STARTED | 67 | 68 |
| COMPLETED | 56 | 62 |
| NOT COMPLETED | 11 | 6 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Vomiting | Gastrointestinal disorders | Sativex: 0 / 67 · Placebo: 1 / 68 |
| Dehydration | Metabolism and nutrition disorders | Sativex: 1 / 67 · Placebo: 1 / 68 |
| Transient Ischaemic Attack | Nervous system disorders | Sativex: 1 / 67 · Placebo: 0 / 68 |
| Dizziness | Nervous system disorders | Sativex: 0 / 67 · Placebo: 1 / 68 |
| Multiple Sclerosis Relapse | Nervous system disorders | Sativex: 0 / 67 · Placebo: 1 / 68 |
| Cystitis Haemorrhagic | Renal and urinary disorders | Sativex: 1 / 67 · Placebo: 0 / 68 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Vomiting Not Otherwise Specified | Gastrointestinal disorders | Sativex: 4 / 67 · Placebo: 2 / 68 |
| Constipation | Gastrointestinal disorders | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Nausea | Gastrointestinal disorders | Sativex: 3 / 67 · Placebo: 3 / 68 |
| Diarrhoea Not Otherwise Specified | Gastrointestinal disorders | Sativex: 2 / 67 · Placebo: 4 / 68 |
| Feeling Drunk | General disorders | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Weakness | General disorders | Sativex: 3 / 67 · Placebo: 2 / 68 |
| Fatigue | General disorders | Sativex: 0 / 67 · Placebo: 3 / 68 |
| Application Site Pain | General disorders | Sativex: 0 / 67 · Placebo: 3 / 68 |
| Urinary tract infection Not Otherwise Specified | Infections and infestations | Sativex: 4 / 67 · Placebo: 7 / 68 |
| Cystitis Not Otherwise Specified | Infections and infestations | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Nasopharyngitis | Infections and infestations | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Dizziness | Nervous system disorders | Sativex: 12 / 67 · Placebo: 5 / 68 |
| Headache Not Otherwise Specified | Nervous system disorders | Sativex: 5 / 67 · Placebo: 5 / 68 |
| Balance Impaired Not Otherwise Specified | Nervous system disorders | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Paraesthesia | Nervous system disorders | Sativex: 3 / 67 · Placebo: 0 / 68 |
| Multiple Sclerosis Relapse | Nervous system disorders | Sativex: 0 / 67 · Placebo: 3 / 68 |
| Disorientation | Psychiatric disorders | Sativex: 4 / 67 · Placebo: 0 / 68 |
| Dissociation | Psychiatric disorders | Sativex: 4 / 67 · Placebo: 0 / 68 |
| Vertigo | Ear and labyrinth disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Abdominal Pain Upper | Gastrointestinal disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Toothache | Gastrointestinal disorders | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Feeling Abnormal | General disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Chest Pain | General disorders | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Pyrexia | General disorders | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Influenza | Infections and infestations | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Pharyngitis Viral Not Otherwise Specified | Infections and infestations | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Anorexia | Metabolism and nutrition disorders | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Neck Pain | Musculoskeletal and connective tissue disorders | Sativex: 0 / 67 · Placebo: 2 / 68 |
| Disturbance in Attention | Nervous system disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Memory Impairment | Nervous system disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Somnolence | Nervous system disorders | Sativex: 2 / 67 · Placebo: 2 / 68 |
| Confusion | Psychiatric disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
| Sweating Increased | Skin and subcutaneous tissue disorders | Sativex: 2 / 67 · Placebo: 0 / 68 |
Time frame: 0 - 10 weeks
Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = "no problems" and 10 = "intolerable problems". Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time frame: 0 - 10 weeks
Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The numbers who scored 1, 2, or 3 are presented.
Time frame: 0 - 10 weeks
Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.