The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.

Condition	Treatment or Intervention	Phase
Pain	Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch	Phase II

Further Study Details: 

Primary Outcomes: To assess the analgesic efficacy of ZR-02-01 versus placebo in patients with moderate to severe OA pain in the hip or knee
Secondary Outcomes: To assess the safety of ZR-02-01; To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health
Expected Total 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   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.

Exclusion Criteria:

• Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.

Arizona
      Arizona Reserach Center, Phoenix,  Arizona,  United States
      Redpoint Research, Phoenix,  Arizona,  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
Florida
      Radiant Research, Daytona Beach,  Florida,  United States
      Tampa Medical Group, Tampa,  Florida,  United States
      Ocala Rheumatology, Ocala,  Florida,  United States
Louisiana
      New Orleans Center for Clinical Research, New Orleans,  Louisiana,  United States
Massachusetts
      Pain Trials Center - Brigham & Women's Hospital, Boston,  Massachusetts,  United States
      Phase III Clinical Trials, Fall River,  Massachusetts,  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
Record last reviewed:  April 2005
Last Updated:  April 18, 2005
Record first received:  April 18, 2005
ClinicalTrials.gov Identifier:  NCT00108771
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03