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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00108771
First received: April 18, 2005
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  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
Drug: Placebo Patch
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • WOMAC Knee and Hip Osteoarthritis Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function)


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • TOPS survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health


Enrollment: 202
Study Start Date: April 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZR-02-01 matrix fentanyl Patch
ZR-02-01 matrix fentanyl patch
 Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.
Other Name: ZR-02-01
Placebo Comparator: Placebo Patch Drug: Placebo Patch
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
Other Name: Placebo Transdermal Matrix Patch

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, 85023
Redpoint Research
Phoenix, Arizona, United States, 85029
United States, California
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92101
Boling Clinical Trials
Upland, California, United States, 91786
United States, Florida
Radiant Research
Daytona Beach, Florida, United States, 32114
Ocala Rheumatology
Ocala, Florida, United States, 34474
Tampa Medical Group
Tampa, Florida, United States, 33614
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
United States, Massachusetts
Pain Trials Center - Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Phase III Clinical Trials
Fall River, Massachusetts, United States, 02720
United States, New York
Analgesic Development Ltd.
New York, New York, United States, 10022
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Frank Farmer, Jr, MD Radiant Research
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00108771     History of Changes
Other Study ID Numbers: ZMF-202
Study First Received: April 18, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain
Chronic Pain
Osteoarthritis Pain
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013