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

Phase 3

Terminated

• Conditions: Pain
• Interventions: Drug: Fentanyl Transdermal Matrix Patch ZR-02-01

• Registration Number: NCT00126763
• Lead Sponsor: ZARS Pharma Inc.

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-02
• Study First Posted: 2005-08-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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.

Exclusion Criteria

• Patient has active cancer
• Patient has a history of substance abuse or has a substance abuse disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matrix Transdermal Fentanyl Patch	Fentanyl Transdermal Matrix Patch ZR-02-01	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse eventsTo	12 months	Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	12 months	Patient will rate pain intensity using a 100 mm VAS in which "0" equals "No Pain" and "100" equals "The Worst Pain You Can Imagine." Patients will be instructed on how to use the VAS and will base their response on the average pain that they experienced over the previous 24 hours. VAS will be collected at all study visits except screening.

Trial Locations

Locations (6)

Drug Studies America; 🇺🇸 Marietta, Georgia, United States

Pain Management Institute; 🇺🇸 Overland Park, Kansas, United States

Loma Linda Center for Pain Management; 🇺🇸 Loma Linda, California, United States

Arizona Reserach Center; 🇺🇸 Phoenix, Arizona, United States

Pain Management Associates; 🇺🇸 Kansas City, Missouri, United States

The Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States