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

ZARS Pharma Inc.202 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

202

Conditions

Pain

Interventions

ZR-02-01 Fentanyl Transdermal Matrix PatchDRUG

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 PatchDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (13)

Arizona Reserach Center

Phoenix, Arizona, United States

Redpoint Research

Phoenix, Arizona, United States

Sharp Rees-Stealy Medical Group

San Diego, California, United States

Outcomes

Primary Outcomes

WOMAC Knee and Hip Osteoarthritis Index

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)

Time frame: 12 weeks

Secondary Outcomes

Number of participants with adverse events

Time frame: 12 weeks

TOPS survey

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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