Fentanyl Transdermal Matrix Patch ZR-02-01 Applied With CHADD™ (Controlled Heat-Assisted Drug Delivery) to Treat Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Chronic Pain - Full Text View

Sponsor:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00278824

Purpose

A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.

Condition	Intervention	Phase
Pain	Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery System	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Multiple Crossover Proof-of-Concept Study to Evaluate the Efficacy of CHADD™ (Controlled Heat-Assisted Drug Delivery) Applied Over a ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Breakthrough Pain in Patients With 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:

Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.

Secondary Outcome Measures:

An adhesion assessment will be conducted by the patient at each CHADD removal.

Estimated Enrollment:	200
Study Start Date:	January 2006

Detailed Description:

ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy.

Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).

The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is 18 through 70 years of age.
Patient has moderate to severe non-malignant chronic pain.
Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks.
Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl.

Exclusion Criteria:

Patient has active cancer.
Patient has a history of substance abuse or has a substance abuse disorder.
Patient is pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278824

Locations

United States, Arizona
Arizona Reserach Center
Phoenix, Arizona, United States, 85023
United States, Florida
Florida's Institute of Clinical Research
Jacksonville, Florida, United States, 32207
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Illinois
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, United States, 60610
United States, Iowa
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States, 50265
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Medical Advanced Pain Specialists
Minneapolis, Minnesota, United States, 55433
United States, Missouri
Pain Management Associates
Independence, Missouri, United States, 64055
United States, New York
Analgesic Development Ltd.
New York, New York, United States, 10022
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Southeast Research Institute
Charlotte, North Carolina, United States, 28203
United States, Oregon
Pain Consultants of Oregon, PC
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Allegheny Pain Management
Altoona, Pennsylvania, United States, 16602
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Virginia
Advanced Pain Management
Virginia Beach, Virginia, United States, 23454

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

No publications provided

Study ID Numbers:	ZCM-201
Study First Received:	January 16, 2006
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00278824 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 04, 2010