Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)
This 9-week study aimed 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 were not required to stop any of their current treatments or medications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean NRS average pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean NRS worst pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean Sleep Disruption NRS [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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)|
Sativex oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
Other Name: Nabiximols
This 9-week, multi-center, double-blind, randomized, placebo-controlled study aimed to determine the efficacy, safety and tolerability of Sativex administered as an adjunctive treatment for 5 weeks, vs. placebo. Eligible patients had advanced cancer, with a clinical diagnosis of cancer related pain which was not wholly alleviated by their current optimized opioid treatment.
Qualifying patients entered the study at Visit 1 and commenced a 5-14 day eligibility period. During this period, eligible patients had 3 consecutive days where pain severity remained within defined parameters, break-through opioid usage had not exceeded an average of 4 episodes per day, and maintenance opioid medication and dose had not changed. Eligible patients returned for a randomization visit (Visit 2, Day 1) and were randomized to either Sativex or placebo using a 1:1 allocation ratio. Patients began an initial titration period lasting up to 14 days; the titration schedule required dosing to a minimum of 3 sprays per day, after which patients were allowed to individualize their dose (3-10 sprays per day) by Day 14, and that dose was then fixed for the remainder of the study. Patients returned at Visit 3 (Day 22) and Visit 4 (Day 36, end of the randomized treatment period), or earlier if they terminated prematurely from the study. After the end of the 5-week treatment period, patients were offered the option of entering an open-label extension (OLE) study; a safety follow up visit (Visit 5) was not required if the patient entered the OLE on the same day as Visit 4. Patients who entered the OLE up to 7 days after Visit 4 had their Visit 5 assessments performed on the same day as their first OLE study visit. Patients that did not enter the OLE study had a safety follow up visit (Visit 5) 14 days after treatment completion, which could be via telephone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361607
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