At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 660 enrolled
Drug / intervention
Nabiximolsdrug
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 Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
In Brief
A Phase 3 clinical trial evaluating Nabiximols for Pain and Advanced Cancer. Completed, enrolled 660 participants across 128 sites in 18 countries.
Detailed Summary
This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Advanced Cancer
CountriesAustralia, Belgium, Bulgaria, Czechia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United Kingdom, United States
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedApr 2011
Primary CompletionJan 2016
TodayJul 2026
First PostedApr 18, 2011
Enrollment StartJan 19, 2011
Primary CompletionJan 27, 2016
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 15.2 years ago
Interventions
Nabiximolsdrug