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

NCT00126763 | Terminated Phase 3

• 1 other identifier: ZMF-303
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 6

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.

Conditions

Pain

Keywords

Chronic Pain; Pain

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse eventsTo

  Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain

  12 months

Secondary Outcomes (1)

• Pain Intensity

  12 months

Study Arms (1)

Matrix Transdermal Fentanyl Patch

EXPERIMENTAL

Drug: Fentanyl Transdermal Matrix Patch ZR-02-01

Interventions

Fentanyl Transdermal Matrix Patch ZR-02-01 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

Also known as: ZR-02-01

Matrix Transdermal Fentanyl Patch

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (6)

Arizona Reserach Center

Phoenix, Arizona, 85023, United States

Location

Loma Linda Center for Pain Management

Loma Linda, California, 92354, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Pain Management Institute

Overland Park, Kansas, 66211, United States

Location

Pain Management Associates

Kansas City, Missouri, 64137, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Rauck, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2005
• First Posted: August 4, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (6)