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

ZARS Pharma

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch; Drug: Placebo Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108771

ZMF-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups, including a placebo group

ZR-02-01 matrix fentanyl Patch

Experimental group

Description:

ZR-02-01 matrix fentanyl patch

Treatment:

Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch

Placebo Patch

Placebo Comparator group

Treatment:

Drug: Placebo Patch