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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.
5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)
No
United States: Food and Drug Administration
GWCA0701
NCT00530764
November 2007
January 2010
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Beth Israel Medical Center | New York, New York 10003 |
Lone Star Oncology | Austin, Texas 78759 |
University of California San Diego | La Jolla, California 92093 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Center For Clinical Research | Winston Salem, North Carolina 27103 |
Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley, California 92708 |
Clinical Pharmacology Services | Tampa, Florida |
Florida Institute of Medical Research | Jacksonville, Florida 32207 |
Loma Linda University | Loma Linda, California 92354 |
Desert Oasis Cancer Center | Casa Grande, Arizona 85222 |
Summit Medical Group | Summit, New Jersey 07901 |
Capital Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Cancer Care Center of Tuscaloosa | Tuscaloosa, Alabama 35406 |
Office of Dr. Ronald Yanagihara | Gilroy, California 95020 |
Center of Hope for Cancer and Blood Disorders | Riverdale, Georgia 30274 |
Louisiana Research Associates | New Orleans, Louisiana 70114 |
The Center for Clinical Research - Washington County Hospital | Hagerstown, Maryland 21740 |
A & A Pain Institute of St. Louis | St. Louis, Missouri 63141 |
Office of Donald H. Berdeaux MD | Great Falls, Montana 59405 |
Metropolitan Hospital Center | New York, New York 10029 |
Four Seasons Hospice & Pallative Care | Flat Rock, North Carolina 28731 |