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

This study has been terminated.
(Difficulty identifying and enrolling eligible patients)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00278824
First received: January 16, 2006
Last updated: June 4, 2012
Last verified: June 2012
  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
Drug: Placebo Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 0, 15, 20, 60 minutes ] [ Designated as safety issue: No ]
    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:
  • Adhesion assessment [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    An adhesion assessment will be conducted by the patient at each CHADD removal.

  • Pain Relief [ Time Frame: 15, 30, 60 minutes ] [ Designated as safety issue: No ]
    Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)

  • Patient's Global Satisfaction Assessment [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

    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.


  • Number of participants with adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    The frequency of adverse events, severity, and relationship to study drug was recorded.


Enrollment: 109
Study Start Date: January 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Placebo Matrix 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Southeast Research Institute
Charlotte, North Carolina, United States, 28203
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
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.
Investigators
Principal Investigator: Lynn R Webster, MD Lifetree Clinical Research
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00278824     History of Changes
Other Study ID Numbers: ZCM-201
Study First Received: January 16, 2006
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Chronic Pain
Pain

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014