Clinical trial NCT00278824: Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
Official title: A Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy of CHADD™ Applied Over a Transdermal Fentanyl Patch for the Treatment of Breakthrough Pain in Patients With Moderate to Severe Non-malignant Chronic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Keywords: Chronic Pain
Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
timeFrame: 0, 15, 20, 60 minutes
Secondary outcomes:
measure: Adhesion assessment
timeFrame: 3 days
measure: Pain Relief
timeFrame: 15, 30, 60 minutes
measure: Patient's Global Satisfaction Assessment
timeFrame: 60 minutes
measure: Number of participants with adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Reserach Center
state: Arizona
city: Jacksonville
country: United States
facility: Florida's Institute of Clinical Research
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Chicago
country: United States
facility: Pain & Rehabilitation Clinic of Chicago
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Medical Advanced Pain Specialists
state: Minnesota
city: Independence
country: United States
facility: Pain Management Associates
state: Missouri
city: New York
country: United States
facility: Analgesic Development Ltd.
state: New York
city: Charlotte
country: United States
facility: Southeast Research Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Eugene
country: United States
facility: Pain Consultants of Oregon, PC
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
Study officials:
affiliation: Lifetree Clinical Research
name: Lynn R Webster, MD
role: PRINCIPAL_INVESTIGATOR
References: