At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 399 enrolled
Drug / intervention
Nabiximols +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blind, Randomized, Placebo-controlled, Parallel Group Study of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy
In Brief
A Phase 3 clinical trial evaluating Nabiximols and Placebo (GA-0034) for Pain and Advanced Cancer. Completed, enrolled 399 participants across 68 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Advanced Cancer
CountriesBulgaria, Czechia, Germany, Hungary, Mexico, Poland, Puerto Rico, Romania, United Kingdom, United States
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartMay 2011
Primary CompletionNov 2014
TodayJul 2026
First PostedMay 27, 2011
Enrollment StartMay 27, 2011
Primary CompletionNov 24, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.1 years ago
Interventions
Nabiximolsdrug
Placebo (GA-0034)drug