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Sponsored by: |
ZARS Pharma Inc. |
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Information provided by: | ZARS Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00108771 |
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain |
Estimated Enrollment: | 200 |
This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona Reserach Center | |
Phoenix, Arizona, United States | |
Redpoint Research | |
Phoenix, Arizona, United States | |
United States, California | |
Boling Clinical Trials | |
Upland, California, United States | |
San Diego Arthritis Medical Clinic | |
San Diego, California, United States | |
Sharp Rees-Stealy Medical Group | |
San Diego, California, United States | |
United States, Florida | |
Radiant Research | |
Daytona Beach, Florida, United States | |
Tampa Medical Group | |
Tampa, Florida, United States | |
Ocala Rheumatology | |
Ocala, Florida, United States | |
United States, Louisiana | |
New Orleans Center for Clinical Research | |
New Orleans, Louisiana, United States | |
United States, Massachusetts | |
Pain Trials Center - Brigham & Women's Hospital | |
Boston, Massachusetts, United States | |
Phase III Clinical Trials | |
Fall River, Massachusetts, United States | |
United States, New York | |
Analgesic Development Ltd. | |
New York, New York, United States | |
Beth Israel Medical Center | |
New York, New York, United States |
Study ID Numbers: | ZMF-202 |
Study First Received: | April 18, 2005 |
Last Updated: | June 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00108771 |
Health Authority: | United States: Food and Drug Administration |
Pain Chronic Pain Osteoarthritis Pain Osteoarthritis |
Fentanyl Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |