Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01361607 |
Recruitment Status :
Completed
First Posted : May 27, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 12, 2023
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | May 25, 2011 | ||
First Posted Date ICMJE | May 27, 2011 | ||
Results First Submitted Date ICMJE | March 23, 2018 | ||
Results First Posted Date ICMJE | April 23, 2018 | ||
Last Update Posted Date | April 12, 2023 | ||
Actual Study Start Date ICMJE | May 27, 2011 | ||
Actual Primary Completion Date | November 24, 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment [ Time Frame: Baseline, End of Treatment (Day 36) ] Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).
Percentage improvement from baseline (Imp%) was calculated as:
Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.
For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive.
|
||
Original 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 ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
|
||
Original Secondary Outcome Measures ICMJE |
|
||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | 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 nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications. |
||
Detailed Description | This 9-week, multi-center, double-blind, randomized, placebo-controlled study aimed to determine the efficacy, safety and tolerability of nabiximols, administered as an adjunctive treatment for 5 weeks, versus placebo. Eligible participants had advanced cancer, with a clinical diagnosis of cancer related pain that was not wholly alleviated by their current optimized opioid treatment. Qualifying participants entered the study at screening and commenced a 5 to 14 day eligibility period. During this period, eligible participants 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 participants returned for randomization on Day 1 and were randomized to either the nabiximols or placebo treatment arm using a 1:1 allocation ratio. Participants began an initial titration period that lasted up to 14 days. The titration schedule required dosing to a minimum of 3 sprays per day, after which participants were allowed to individualize their dose (3 to 10 sprays per day) until Day 14 when that dose was then fixed for the remainder of the study. Participants returned at Day 22 and 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, participants were offered the option of entering an open-label extension (OLE) study; a safety follow up visit (up to Day 43) was not required if the participant entered the OLE on Day 36. Participants who entered the OLE, up to 7 days after study completion had their follow-up assessments performed on the same day as their first OLE study visit. Participants that did not enter the OLE study had a safety follow up visit 14 days after treatment completion, which could be via telephone. |
||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
||
Condition ICMJE |
|
||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * | Fallon MT, Albert Lux E, McQuade R, Rossetti S, Sanchez R, Sun W, Wright S, Lichtman AH, Kornyeyeva E. Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies. Br J Pain. 2017 Aug;11(3):119-133. doi: 10.1177/2049463717710042. Epub 2017 May 17. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
399 | ||
Original Estimated Enrollment ICMJE |
380 | ||
Actual Study Completion Date ICMJE | November 24, 2014 | ||
Actual Primary Completion Date | November 24, 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria (abbreviated):
Exclusion Criteria (abbreviated):
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Bulgaria, Czechia, Germany, Hungary, Mexico, Poland, Puerto Rico, Romania, United Kingdom, United States | ||
Removed Location Countries | Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT01361607 | ||
Other Study ID Numbers ICMJE | GWCA0962 2009-016065-29 ( EudraCT Number ) |
||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Jazz Pharmaceuticals | ||
Original Responsible Party | Matthew Hersch, GW Pharmaceuticals Ltd. | ||
Current Study Sponsor ICMJE | Jazz Pharmaceuticals | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Jazz Pharmaceuticals | ||
Verification Date | April 2023 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |