Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
TerminatedPhase 2NCT00278824
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Interventions
- Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery System
- Drug: Placebo Patch
- Sponsor
- ZARS Pharma Inc.
- Start date
- 2006-01
- Primary completion
- 2006-08
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 15
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00278824