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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126763
Recruitment Status : Terminated (PK results suggested product did not meet requirement for further development.)
First Posted : August 4, 2005
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Fentanyl Transdermal Matrix Patch ZR-02-01 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Non-Malignant Chronic Pain
Study Start Date : July 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Matrix Transdermal Fentanyl Patch Drug: 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
Other Name: ZR-02-01

Primary Outcome Measures :
  1. Number of participants with adverse eventsTo [ Time Frame: 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 :
  1. Pain Intensity [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126763

United States, Arizona
Arizona Reserach Center
Phoenix, Arizona, United States, 85023
United States, California
Loma Linda Center for Pain Management
Loma Linda, California, United States, 92354
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Kansas
Pain Management Institute
Overland Park, Kansas, United States, 66211
United States, Missouri
Pain Management Associates
Kansas City, Missouri, United States, 64137
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
ZARS Pharma Inc.
Principal Investigator: Richard Rauck, MD The Center for Clinical Research

Responsible Party: ZARS Pharma Inc. Identifier: NCT00126763     History of Changes
Other Study ID Numbers: ZMF-303
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by ZARS Pharma Inc.:
Chronic Pain

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General