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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ZARS Pharma Inc.

ClinicalTrials.gov Identifier:

NCT00108771

First received: April 18, 2005

Last updated: June 4, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2005

Last Updated Date

June 4, 2012

Start Date ^ICMJE

April 2004

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

WOMAC Knee and Hip Osteoarthritis Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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)

Original Primary Outcome Measures ^ICMJE

To assess the analgesic efficacy of ZR-02-01 versus placebo in patients with moderate to severe OA pain in the hip or knee

Change History

Complete list of historical versions of study NCT00108771 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
TOPS survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

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 Name: 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 Name: Placebo Transdermal Matrix Patch

Study Arm (s)

Experimental: ZR-02-01 matrix fentanyl Patch
ZR-02-01 matrix fentanyl patch

Intervention: Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch
Placebo Comparator: Placebo Patch
Intervention: Drug: Placebo Patch

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

202

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00108771

Other Study ID Numbers ^ICMJE

ZMF-202

Has Data Monitoring Committee

Responsible Party

ZARS Pharma Inc.

Study Sponsor ^ICMJE

ZARS Pharma Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Frank Farmer, Jr, MD

Radiant Research

Information Provided By

ZARS Pharma Inc.

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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