A Study of Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT01262651|
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : July 6, 2016
This 9-week study will aim to determine the efficacy, safety and tolerability of Sativex® (Nabiximols) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in patients with advanced cancer.
Eligible patients will not be required to stop any of their current treatments or medications.
|Condition or disease||Intervention/treatment||Phase|
|Pain Advanced Cancer||Drug: Sativex® Drug: Placebo (GA-0034)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||397 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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.|
|Study Start Date :||November 2010|
|Primary Completion Date :||June 2015|
|Study Completion Date :||July 2015|
Sativex oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
Other Name: Nabiximols
Placebo Comparator: Placebo (GA-0034)
Placebo oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
|Drug: Placebo (GA-0034)|
- The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. [ Time Frame: 5 weeks ]
- Change from baseline in mean NRS average pain [ Time Frame: 5 weeks ]
- Change from baseline in mean NRS worst pain [ Time Frame: 5 weeks ]
- Change from baseline in mean Sleep Disruption NRS [ Time Frame: 5 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262651
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