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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108771
• Other study ID #: ZMF-202
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2005
• Last updated: June 4, 2012
• Start date: April 2004
• Est. completion date: September 2006

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Pain Trials Center - Brigham & Women's Hospital	Boston	Massachusetts
United States	Radiant Research	Daytona Beach	Florida
United States	Phase III Clinical Trials	Fall River	Massachusetts
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Analgesic Development Ltd.	New York	New York
United States	Beth Israel Medical Center	New York	New York
United States	Ocala Rheumatology	Ocala	Florida
United States	Arizona Reserach Center	Phoenix	Arizona
United States	Redpoint Research	Phoenix	Arizona
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Tampa Medical Group	Tampa	Florida
United States	Boling Clinical Trials	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Knee and Hip Osteoarthritis Index	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)	12 weeks	No
Secondary	Number of participants with adverse events		12 weeks	Yes
Secondary	TOPS survey	To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health	12 weeks	No