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| Sponsor: | GW Pharmaceuticals Ltd. |
|---|---|
| Collaborator: |
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 |
| 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: | November 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 110 Study Locations
More Information
| Responsible Party: | GW Pharmaceuticals Ltd ( Clinical Project Manager ) |
| Study ID Numbers: | GWCA0701 |
| Study First Received: | September 13, 2007 |
| Last Updated: | October 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00530764 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pain Cancer Palliative |