A Study of Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01262651
First received: December 16, 2010
Last updated: July 4, 2016
Last verified: July 2016

December 16, 2010
July 4, 2016
November 2010
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01262651 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pain
  • Advanced Cancer
  • Drug: Sativex®
    Other Name: Nabiximols
  • Drug: Placebo (GA-0034)
  • Experimental: Sativex®
    Sativex oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
    Intervention: Drug: Sativex®
  • Placebo Comparator: Placebo (GA-0034)
    Placebo oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
    Intervention: Drug: Placebo (GA-0034)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
397
July 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria (abbreviated):

  • The patient has advanced cancer for which there is no known curative therapy
  • The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
  • The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
  • The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
  • The patient is using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

  • Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
  • The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
  • Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
  • Has significantly impaired renal function
  • Has significantly impaired hepatic function
  • Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Czech Republic,   Germany,   Hungary,   Latvia,   Lithuania,   Poland,   Puerto Rico,   Romania,   United Kingdom
Croatia,   Estonia
 
NCT01262651
GWCA0958, 2009-016064-36
Yes
Not Provided
Not Provided
GW Pharmaceuticals Ltd.
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
GW Pharmaceuticals Ltd.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP