|
|
|
|
|
|
Sponsored by: |
GW Pharmaceuticals Ltd. |
Information provided by: | GW Pharmaceuticals Ltd. |
ClinicalTrials.gov Identifier: | NCT00674609 |
The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
Condition | Intervention | Phase |
Palliative Care Pain Cancer |
Drug: Placebo Drug: Sativex® Drug: GW-2000-02 |
Phase III |
MedlinePlus related topics: | Cancer Palliative Care |
Drug Information available for: | Tetrahydrocannabinol Cannabis GW-1000 Cannabidiol |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-Related Pain. |
Enrollment: | 177 |
Study Start Date: | February 2002 |
Study Completion Date: | March 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Placebo Comparator |
Drug: Placebo
Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
|
B: Experimental |
Drug: Sativex®
Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
|
C: Experimental |
Drug: GW-2000-02
Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
|
This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |||||
Shropshire and Mid-Wales Hospice | |||||
Shrewsbury, United Kingdom, SY3 8HS |
GW Pharmaceuticals Ltd. |
Principal Investigator: | Jeremy R Johnson, MB ChB | Shropshire and Mid-Wales Hospice |
Responsible Party: | GW Pharmaceuticals Ltd. ( Mr Richard Potts/ Clinical Operations Director ) |
Study ID Numbers: | GWCA0101 |
First Received: | April 28, 2008 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00674609 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Romania: National Medicines Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
|
|