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

Phase 3

Terminated

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

• Registration Number: NCT00126789
• 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 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-02
• Study First Posted: 2005-08-04
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZR-02-01	Fentanyl Transdermal Matrix Patch ZR-02-01	ZR-02-01 matrix transdermal fentanyl patch

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

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