Phase 3
N=406
A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
Pain · Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01424566 ↗Enrolled (actual)
406
Serious AEs
21.2%
Results posted
Apr 2018
Primary outcome: Primary: Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment — 0.5; 0.5 units on a scale — p=0.9173
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
- Jazz Pharmaceuticals
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment |
0.5; 0.5 | 0.9173 |
| SECONDARY Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment |
33.3; 35.7 | — |
| SECONDARY Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment |
0.2; 0.5 | — |
| SECONDARY Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment |
0.2; 0.5 | — |
| SECONDARY Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) |
6; 6; 28; 35; 35; 26 | — |
| SECONDARY Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) |
7; 7; 22; 30; 37; 25 | — |
| SECONDARY Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period) |
5; 5; 30; 38; 35; 28 | — |
| SECONDARY Change From Randomization Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment |
9.0; 15.5 | — |
| SECONDARY Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment |
0.0; 8.5 | — |
| SECONDARY Change From Randomization Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment |
9.0; 7.0 | — |
| SECONDARY Change From Randomization Baseline In NRS Constipation At Last Visit (Up To Day 36 Of The Double-blind Period) |
0.0; -0.2 | — |
Summary
The primary objective of this study was to evaluate the efficacy of nabiximols (Sativex®), compared with placebo, when used as an adjunctive measure in relieving uncontrolled persistent chronic pain (not breakthrough pain) in participants with advanced cancer, who had inadequate analgesia even with optimized chronic opioid therapy.
This multi-center study was conducted in two parts. All participants enrolled into the trial received nabiximols during one of two parts of the study, but they did not know which part.
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 is no known curative therapy
- The participant had a clinical diagnosis of cancer related pain, which was not 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):
- 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 currently using or had used cannabis or cannabinoid-based medications within 30 days of study entry and was unwilling to abstain for the duration of the study
- 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
- Had significantly impaired renal function
- 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 three 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 (NCT01424566). 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.