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. Identifier: NCT01361607
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : July 6, 2016
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

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.

Condition or disease Intervention/treatment Phase
Pain Advanced Cancer Drug: Sativex® Drug: Placebo (GA-0034) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Placebo Comparator: Placebo (GA-0034)
Placebo oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
Drug: Placebo (GA-0034)
Experimental: Sativex®
Sativex oromucosal spray. 100 μl administered twice daily up to a maximum of 10 sprays per day.
Drug: Sativex®
Other Name: Nabiximols

Primary Outcome Measures :
  1. The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in mean NRS average pain [ Time Frame: 5 weeks ]
  2. Change from baseline in mean NRS worst pain [ Time Frame: 5 weeks ]
  3. Change from baseline in mean Sleep Disruption NRS [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01361607

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Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: GW Pharmaceuticals Ltd. Identifier: NCT01361607     History of Changes
Other Study ID Numbers: GWCA0962
2009-016065-29 ( EudraCT Number )
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by GW Pharmaceuticals Ltd.:
Cancer pain
Opioid therapy
Inadequate analgesia
Optimized chronic opioid therapy

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents