Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-12-31

Brief Summary

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

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Detailed Description

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This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe non-malignant chronic 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

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days

Interventions

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Fentanyl Transdermal Matrix Patch ZR-02-01

ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days

Intervention Type DRUG

Other Intervention Names

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ZR-02-01

Eligibility Criteria

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Inclusion Criteria

* Patient is at least 18 and no older than 75 years of age
* Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
* Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.