Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain - Full Text View

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00108771

Purpose

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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Fentanyl Citrate Fentanyl

U.S. FDA Resources

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

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:

200

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108771

Locations

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

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

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

Keywords provided by ZARS Pharma Inc.:

Pain
Chronic Pain
Osteoarthritis Pain
Osteoarthritis

Study placed in the following topic categories:

Fentanyl
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009