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

Sponsor:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00126763

Purpose

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	Intervention	Phase
Pain	Drug: Fentanyl Transdermal Matrix Patch ZR-02-01	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

To 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:

To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe, non-malignant chronic pain being treated with the ZR-02-01 matrix transdermal fentanyl patch

Estimated Enrollment:	200
Study Start Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126763

Locations

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.

More Information

No publications provided

Study ID Numbers:	ZMF-303
Study First Received:	August 2, 2005
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00126763 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:

Chronic Pain
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010