Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00278824

Run by

ZARS Pharma Inc.

People needed

109

Starts

2006-01-01

Expected to finish

2006-08-01

Last updated by the study team

2012-06-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.