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Completed

NCT Number: NCT00108771

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

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

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Key information

Conditions

Pain Arthritis Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Reserach Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZR-02-01 Fentanyl Transdermal Matrix Patch

Drug

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

Placebo Patch

Drug

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

Primary outcomes

  1. WOMAC Knee and Hip Osteoarthritis Index

    Time frame: 12 weeks

    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 outcomes

  1. Number of participants with adverse events

    Time frame: 12 weeks

  2. TOPS survey

    Time frame: 12 weeks

    To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 19, 2005
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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