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