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

NCT ID: NCT00108771

Last Updated: 2012-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZR-02-01 matrix fentanyl Patch

ZR-02-01 matrix fentanyl patch

Group Type EXPERIMENTAL

ZR-02-01 Fentanyl Transdermal Matrix Patch

Intervention Type 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.

Placebo Patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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ZR-02-01 Placebo Transdermal Matrix Patch

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZARS Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Farmer, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Locations

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Arizona Reserach Center

Phoenix, Arizona, United States

Site Status

Redpoint Research

Phoenix, Arizona, United States

Site Status

Sharp Rees-Stealy Medical Group

San Diego, California, United States

Site Status

San Diego Arthritis Medical Clinic

San Diego, California, United States

Site Status

Boling Clinical Trials

Upland, California, United States

Site Status

Radiant Research

Daytona Beach, Florida, United States

Site Status

Ocala Rheumatology

Ocala, Florida, United States

Site Status

Tampa Medical Group

Tampa, Florida, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

Pain Trials Center - Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Phase III Clinical Trials

Fall River, Massachusetts, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Analgesic Development Ltd.

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ZMF-202

Identifier Type: -

Identifier Source: org_study_id

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