Trial | NCT00108771  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Pain

  • Intervention/Treatment

    fentanyl ...

  • Study Participants

    202
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
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.
Study Started
Apr 30
2004
Primary Completion
Sep 30
2006
Study Completion
Sep 30
2006
Last Update
Jun 05
2012
Estimate

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 names: ZR-02-01

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 names: Placebo Transdermal Matrix Patch

ZR-02-01 matrix fentanyl Patch Experimental

ZR-02-01 matrix fentanyl patch

Placebo Patch Placebo Comparator

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.
No Results Posted