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Sponsors and Collaborators: |
GW Pharmaceuticals Ltd. Quintiles |
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Information provided by: | GW Pharmaceuticals Ltd. |
ClinicalTrials.gov Identifier: | NCT00530764 |
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 |
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Palliative Care Pain Cancer |
Drug: GW-1000-02 |
Phase II |
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. |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew Hersch, MSc | +44 (0) 1353 616600 | mhersch@gwpharm.com |
Contact: Elizabeth Lawler | +1 609-814-0988 | Elizabeth Lawler@Quintiles.com |
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 |
Pain Cancer Palliative |
Pain |