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

Condition(s) targeted: Pain

Intervention: Matrix Transdermal Fentanyl/CHADD Drug Delivery System (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: ZARS Pharma Inc.

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Arizona Reserach Center, Phoenix, Arizona 85023, United States

Florida's Institute of Clinical Research, Jacksonville, Florida 32207, United States

Drug Studies America, Marietta, Georgia 30060, United States

Pain & Rehabilitation Clinic of Chicago, Chicago, Illinois 60610, United States

Integrated Clinical Trial Services, Inc., West Des Moines, Iowa 50265, United States

Brigham & Women's Hospital, Boston, Massachusetts 02115, United States

Medical Advanced Pain Specialists, Minneapolis, Minnesota 55433, United States

Pain Management Associates, Independence, Missouri 64055, United States

Analgesic Development Ltd., New York, New York 10022, United States

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States

Southeast Research Institute, Charlotte, North Carolina 28203, United States

Pain Consultants of Oregon, PC, Eugene, Oregon 97401, United States

Allegheny Pain Management, Altoona, Pennsylvania 16602, United States

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States

Advanced Pain Management, Virginia Beach, Virginia 23454, United States

Starting date: January 2006
Last updated: September 19, 2007