A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

This study is currently recruiting participants.
Verified January 2014 by GW Pharmaceuticals Ltd.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01424566
First received: August 25, 2011
Last updated: March 26, 2014
Last verified: January 2014

August 25, 2011
March 26, 2014
January 2012
September 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01424566 on ClinicalTrials.gov Archive Site
  • Percentage improvement in NRS average pain score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Mean 11-point NRS worst pain score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Mean sleep disruption NRS score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pain
  • Advanced Cancer
  • Drug: Sativex®
    100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day
    Other Names:
    • Sativex® oromucosal spray
    • Nabiximols
  • Drug: Placebo (product code GA0034)
    Matching placebo: oromucosal spray, containing excipients, peppermint flavored
    Other Name: Product code GA0034
  • Active Comparator: Sativex® Treatment
    Intervention: Drug: Sativex®
  • Placebo Comparator: Placebo Treatment
    Intervention: Drug: Placebo (product code GA0034)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
December 2015
September 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 three 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
No
Contact: SPRAY Study Information SPRAYInfo@mmgct.com
Australia,   Chile,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Poland,   Romania,   Spain,   Taiwan,   United Kingdom
 
NCT01424566
GWCA1103, 2010-022905-17
Yes
GW Pharmaceuticals Ltd.
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
GW Pharmaceuticals Ltd.
January 2014

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