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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pain, Advanced Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score.

Outcome Time Frame:

5 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GWCA0962

NCT ID:

NCT01361607

Start Date:

May 2011

Completion Date:

February 2014

Related Keywords:

  • Pain
  • Advanced Cancer
  • Cancer pain
  • Opioid therapy
  • inadequate analgesia
  • optimized chronic opioid therapy
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
Kansas City, Kansas  66160
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Jackson, Mississippi  
Bismarck, North Dakota  58501