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

This study is currently recruiting participants. (see Contacts and Locations)
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: May 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pain
Advanced Cancer
Drug: Sativex®
Drug: Placebo (product code GA0034)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 540
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sativex® Treatment Drug: Sativex®
100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day
Other Names:
  • Sativex® oromucosal spray
  • Nabiximols
Placebo Comparator: Placebo Treatment Drug: Placebo (product code GA0034)
Matching placebo: oromucosal spray, containing excipients, peppermint flavored
Other Name: Product code GA0034

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424566

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Show 111 Study Locations
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01424566     History of Changes
Other Study ID Numbers: GWCA1103, 2010-022905-17
Study First Received: August 25, 2011
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GW Pharmaceuticals Ltd.:
cancer pain
opioid therapy
inadequate analgesia
optimized chronic opioid therapy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014