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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery System; Drug: Placebo Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mcg/hr matrix fentanyl patch; active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)	Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery System; Patch applied every 3 days for 15 days; Other Names: ZR-02-01; Fentanyl Transdermal Matrix Patch
Placebo Comparator: Placebo Patch; placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch	Drug: Placebo Patch; Placebo patch applied every 3 days for 15 days; Other Names: Placebo Matrix Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0, 15, 20, 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion assessment	An adhesion assessment will be conducted by the patient at each CHADD removal.	3 days
Pain Relief	Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)	15, 30, 60 minutes
Patient's Global Satisfaction Assessment	Patients completed a global satisfaction assessment 60 minutes after CHADD application. Patients were asked to assess their overall satisfaction with the CHADD throughout the 60 minute application period for the treatment of their breakthrough pain using the following 5-point scale: 0=not satisfied, 1=somewhat satisfied, 2=moderately satisfied, 3=very satisfied, and 4=completely satisfied.	60 minutes
Number of participants with adverse events	The frequency of adverse events, severity, and relationship to study drug was recorded.	15 days

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: January 16, 2006
• First Submitted That Met QC Criteria: January 16, 2006
• First Posted (Estimate): January 18, 2006

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Chronic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: ZCM-201