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A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

CompletedPhase 3NCT01424566
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Two-part, Placebo-controlled, Study of the Safety and Efficacy of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients With Advanced Cancer, Who Have Inadequate Analgesia Even With Optimized Chronic Opioid Therapy.
Conditions
Interventions
Sponsor
Jazz Pharmaceuticals
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date
2012-06-29
Primary completion
2015-07-10
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Australia, Bulgaria, Germany, Hungary, India, Israel, Italy, Lithuania, Poland, Romania, Spain, Taiwan, United Kingdom
Total sites listed
65

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01424566