CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 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.

Search/NCT01262651
NCT01262651Phase 3Completed
CompareCT.gov

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

GW Pharmaceuticals Ltd·interventional·Posted Dec 17, 2010·Updated Apr 23, 2018

In Brief

A Phase 3 clinical trial evaluating Nabiximols and Placebo (GA-0034) for Pain and Advanced Cancer. Completed, enrolled 397 participants across 72 sites in 12 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
CountriesBelgium, Bulgaria, Czechia, Germany, Hungary, Latvia, Lithuania, Poland, Puerto Rico, Romania, United Kingdom, United States
CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2010
Enrollment StartNov 25, 2010
Primary CompletionJul 2, 2015
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.5 years ago

Interventions

Nabiximolsdrug

Placebo (GA-0034)drug