A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy
|ClinicalTrials.gov Identifier: NCT00710424|
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : July 31, 2012
Last Update Posted : August 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pain Diabetic Neuropathy||Drug: Sativex Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||297 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex in the Treatment of Subjects With Pain Due to Diabetic Neuropathy|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Other Name: GW-1000-02
|Placebo Comparator: Placebo||
containing 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.
Other Name: GW-4001-01
- The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) [ Time Frame: Day 0 to Day 98 ]The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours" where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis.
- Number of Responders at the 30% Improvement Level at the End of Treatment [ Time Frame: Day 0 - Day 98 ]A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). 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. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period.
- Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment [ Time Frame: Day 0 to Day 98 ]The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.
- Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment [ Time Frame: Day 0 - Day 98 ]The sleep quality Numerical Rating Scale 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 the number that best describes your sleep quality in the last 24 hours" where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment).
- Subject Global Impression of Change at the End of Treatment [ Time Frame: Day 0 and Day 98 ]The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.
- Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment [ Time Frame: Day 0 and Day 98 ]The brief pain inventory (short form) 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 pain 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.
- Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale [ Time Frame: Day 0 and Day 98 ]The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
- Change From Baseline in the Use of Rescue Analgesia at the End of Treatment [ Time Frame: Day 0 - Day 98 ]The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.
- Incidence of Adverse Events as a Measure of Subject Safety [ Time Frame: Day 0 - Day 133 ]The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.
- Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment [ Time Frame: Day 0 - Day 98 ]Subjects rated their intoxication levels on a scale of 0-10, where 0 equals "no intoxication" and 10 equals "extreme intoxication". A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710424
|Royal Hallamshire Hospital|
|Sheffield, Yorkshire, United Kingdom, S10 2JF|
|Principal Investigator:||Solomon Tesfaye, JCHMT FRCP||Royal Hallamshire Hospital|