Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)
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ClinicalTrials.gov Identifier: NCT01361607 |
Recruitment Status
:
Completed
First Posted
: May 27, 2011
Last Update Posted
: July 6, 2016
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Tracking Information | |||
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First Submitted Date ICMJE | May 25, 2011 | ||
First Posted Date ICMJE | May 27, 2011 | ||
Last Update Posted Date | July 6, 2016 | ||
Study Start Date ICMJE | May 2011 | ||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. [ Time Frame: 5 weeks ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01361607 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer | ||
Official Title ICMJE | 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 | ||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
399 | ||
Original Estimated Enrollment ICMJE |
380 | ||
Actual Study Completion Date | November 2014 | ||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria (abbreviated):
Exclusion Criteria (abbreviated):
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Bulgaria, Czech Republic, Germany, Hungary, Mexico, Poland, Puerto Rico, Romania, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01361607 | ||
Other Study ID Numbers ICMJE | GWCA0962 2009-016065-29 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | GW Pharmaceuticals Ltd. | ||
Study Sponsor ICMJE | GW Pharmaceuticals Ltd. | ||
Collaborators ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
Investigators ICMJE | Not Provided | ||
PRS Account | GW Pharmaceuticals Ltd. | ||
Verification Date | July 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |