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

Phase 3TerminatedNCT00126789

ZARS Pharma Inc.24 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Cancer

Interventions

Fentanyl Transdermal Matrix Patch ZR-02-01DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Loma Linda Center for Pain Management

Loma Linda, California, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Number of participants with adverse events

To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain

Time frame: 12 weeks

Secondary Outcomes

Pain intensity

Patient's evaluation of pain intensity using the VAS (100 mm)

Time frame: 12 weeks

Global Satisfaction satisfied)

Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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