Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)
This study is currently recruiting participants.
Verified by GW Pharmaceuticals Ltd., December 2008
Sponsors and Collaborators: GW Pharmaceuticals Ltd.
Quintiles
Information provided by: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00530764
  Purpose

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.


Condition Intervention Phase
Palliative Care
Pain
Cancer
Drug: GW-1000-02
Phase II

MedlinePlus related topics: Cancer Palliative Care
Drug Information available for: Cannabis GW-1000
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-Range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) during the last three days of week 5.

Secondary Outcome Measures:
  • Cumulative average pain response curves
  • Mean daily IVRS NRS pain score (average and also worst pain).
  • Brief Pain Inventory - Short Form
  • Sleep Disruption NRS
  • Patient Assessment of Constipation Quality of Life (PAC-QoL)
  • Patient Global Impression of Change - PGIC
  • Montgomery Asberg Depression Rating Scale (MADRS)
  • Addiction Research Center Inventory (ARCI)

Estimated Enrollment: 336
Study Start Date: November 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • The patient has advanced active cancer for which there is no known curative therapy.
  • The patient is able (in the investigators opinion) and willing to comply with all study requirements.
  • The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
  • The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the WHO analgesic ladder.
  • The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.

Exclusion Criteria:

  • The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
  • The patient is currently using two or more types of break-through opioid analgesia (IR).
  • Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
  • Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
  • The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
  • The patient has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia or myocardial infarction.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530764

Contacts
Contact: Matthew Hersch, MSc +44 (0) 1353 616600 mhersch@gwpharm.com
Contact: Elizabeth Lawler +1 609-814-0988 Elizabeth Lawler@Quintiles.com

  Show 63 Study Locations
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Quintiles
  More Information

Responsible Party: GW Pharmaceuticals Ltd ( Clinical Project Manager )
Study ID Numbers: GWCA0701
Study First Received: September 13, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00530764  
Health Authority: United States: Food and Drug Administration

Keywords provided by GW Pharmaceuticals Ltd.:
Pain
Cancer
Palliative

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 16, 2009