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

NCT ID: NCT00126789

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-07-31

Brief Summary

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

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.

Conditions

Pain; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZR-02-01

ZR-02-01 matrix transdermal fentanyl patch

Group Type: EXPERIMENTAL

Fentanyl Transdermal Matrix Patch ZR-02-01

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ZR-02-01 matrix transdermal fentanyl patch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Rauck, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Clinical Research

Locations

Loma Linda Center for Pain Management

Loma Linda, California, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

ZMF-301

Identifier Type: -

Identifier Source: org_study_id