Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain

June 4, 2012 updated by: ZARS Pharma Inc.

An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain

The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe cancer pain currently taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study. Patient's dose of ZR-02-01 will be determined by the investigator using sponsor-provided conversion. Pain therapy will be under the supervision of the physician investigator.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda Center for Pain Management
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is at least 18 and no older than 75 years of age at the time of screening
  • Patient has a diagnosis of cancer
  • Patient has moderate to severe pain that is related to cancer or its treatment and is expected to last indefinitely and is currently taking an around-the-clock opioid to treat his/her pain
  • Patient is already receiving opioid therapy, has demonstrated opioid tolerance
  • A responsible adult caregiver is available in the event of an emergency at home

Exclusion Criteria:

  • Patient has uncontrolled or rapidly escalating pain as determined by the investigator
  • Patient has a history of substance abuse or has a substance abuse disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZR-02-01
ZR-02-01 matrix transdermal fentanyl patch
Drug: Fentanyl Transdermal Matrix Patch ZR-02-01
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
Other Names:
  • ZR-02-01 matrix transdermal fentanyl patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: 12 weeks
To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 12 weeks
Patient's evaluation of pain intensity using the VAS (100 mm)
12 weeks
Global Satisfaction satisfied)
Time Frame: 12 weeks
Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Principal Investigator: Richard Rauck, MD, The Center for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 4, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZMF-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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