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NCT00278824 · ClinicalTrials.gov registry record · Phase 2
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
A Phase 2 study, sponsored by ZARS Pharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT00278824: Clinical Trial Phase 2 study, sponsored by ZARS Pharma.
NCT00278824 is a Phase 2 study that was terminated before completion, run by ZARS Pharma. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00278824, a Phase 2 study, was terminated before completion, sponsored by ZARS Pharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo Patch
- DRUG Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
Why NCT00278824 stopped before completion
NCT00278824 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Patch is the first listed.
NCT00278824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00278824 about?
NCT00278824 is a clinical study titled "Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant 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 wi...
What is the current status of trial NCT00278824?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2006-01. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00278824?
The interventions under investigation include: Placebo Patch (DRUG), Matrix Transdermal Fentanyl/CHADD Drug Delivery System (DRUG).
Who is sponsoring clinical trial NCT00278824?
This trial is sponsored by ZARS Pharma, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00278824's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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