Phase 3
N=397
Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer
Pain · Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01262651 ↗Enrolled (actual)
397
Serious AEs
22.7%
Results posted
Apr 2018
Primary outcome: Primary: Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment — 10.7; 4.5 percent improvement — p=0.0854
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nabiximols (Drug); Placebo (GA-0034) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GW Pharmaceuticals Ltd
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment |
10.7; 4.5 | 0.0854 |
| SECONDARY Change From Baseline In Mean NRS Average Pain At End Of Treatment |
-0.8; -0.6 | — |
| SECONDARY Change From Baseline In Mean NRS Worst Pain At End Of Treatment |
-0.9; -0.8 | — |
| SECONDARY Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment |
-0.8; -0.5 | — |
| SECONDARY Subject Global Impression Of Change At Last Visit (Up To Day 36) |
5; 3; 34; 26; 60; 55 | — |
| SECONDARY Physician Global Impression Of Change At Last Visit (Up To Day 36) |
6; 3; 37; 25; 56; 50 | — |
| SECONDARY Patient Satisfaction Questionnaire At Last Visit (Up To Day 36) |
7; 3; 42; 38; 42; 37 | — |
| SECONDARY Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment |
0.3; 0.6 | — |
| SECONDARY Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment |
0.2; -1.3 | — |
| SECONDARY Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment |
0.1; 1.8 | — |
| SECONDARY Change From Baseline In NRS Constipation At Last Visit (Up To Day 36) |
-0.6; -0.3 | — |
Summary
This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer.
Eligible participants were not required to stop any of their current treatments or medications.
Eligibility Criteria
Inclusion Criteria (abbreviated):
- The participant had advanced cancer for which there was no known curative therapy
- The participant had a clinical diagnosis of cancer related pain, which was not wholly alleviated with their current optimized opioid treatment
- The participant received an optimized maintenance dose of Step 3 opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
- The participant received a daily maintenance dose Step 3 opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
- The participant was using no more than one type of break-through opioid analgesia
Exclusion Criteria (abbreviated):
- The participant had any planned clinical interventions that would have affected their pain (for example, chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
- The participant was using or had used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
- The participant had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator, would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
- The participant had significantly impaired renal function
- The participant had significantly impaired hepatic function
- Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom was not to be used in conjunction with a female condom as this may not have proven effective)
Data sourced from ClinicalTrials.gov (NCT01262651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.