A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT01424566|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : July 6, 2016
The primary objective of this study is to determine the efficacy of Sativex, compared with placebo, an adjunctive medication in relieving persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have this pain even when they are on optimized/maximized chronic opioid therapy.
This multi-center study will be conducted in two parts. All participants enrolled into the trial will receive Sativex during one of two parts of the study, but they will not know which part.
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 (product code GA0034)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||January 2012|
|Primary Completion Date :||July 2015|
|Study Completion Date :||December 2015|
|Active Comparator: Sativex® Treatment||
100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day
|Placebo Comparator: Placebo Treatment||
Drug: Placebo (product code GA0034)
Matching placebo: oromucosal spray, containing excipients, peppermint flavored
Other Name: Product code GA0034
- Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS [ Time Frame: 7 weeks ]
- Percentage improvement in NRS average pain score from baseline to the end of treatment [ Time Frame: 7 weeks ]
- Mean 11-point NRS worst pain score from baseline to the end of treatment [ Time Frame: 7 weeks ]
- Mean sleep disruption NRS score from baseline to the end of treatment [ Time Frame: 7 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424566
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