NCT00108771

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pain

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-04-19
• Last updated: 2012-06-05

Locations

13 sites across 1 country: United States