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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00278824
• Other study ID #: ZCM-201
• Status: Terminated
• Phase: Phase 2
• First received: January 16, 2006
• Last updated: June 4, 2012
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Pain

Intervention

Drug:
• Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Patch applied every 3 days for 15 days
• Placebo Patch
Placebo patch applied every 3 days for 15 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adhesion assessment	An adhesion assessment will be conducted by the patient at each CHADD removal.	3 days	Yes
Secondary	Pain Relief	Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)	15, 30, 60 minutes	No
Secondary	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	No
Secondary	Number of participants with adverse events	The frequency of adverse events, severity, and relationship to study drug was recorded.	15 days	Yes