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NCT00695565 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
A Phase 2 study of Painful Diabetic Neuropathy, sponsored by Arcion Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 16
- Study locations
NCT00695565: Completed Phase 2 study of Painful Diabetic Neuropathy, sponsored by Arcion Therapeutics.
NCT00695565 is a Phase 2 study of Painful Diabetic Neuropathy that has completed, run by Arcion Therapeutics. The registered enrollment target is 180 participants, above the 96-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (88% higher). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00695565, a Phase 2 study of Painful Diabetic Neuropathy, has completed, sponsored by Arcion Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
Primary Outcome
Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain". The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief).
Conditions Studied
Interventions
- DRUG Placebo Gel
- DRUG Clonidine Topical Gel (ARC-4558)
Study Locations (16)
California
- Northern California Research - Sacramento
- Neurological Research Institute - Santa Monica
Texas
- The Nerve and Muscle Center of Texas - Houston
- Diabetes and Glandular Disease Center - San Antonio
Alabama
- University of Alabama at Birmingham, School of Medicine - Birmingham
Florida
- Metabolic Research Institute - West Palm Beach
Kentucky
- Pain Treatment Center of the Bluegrass - Lexington
Louisiana
- Tulane University Health Sciences Center - New Orleans
Massachusetts
- University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office - Worcester
Nebraska
- The Creighton Diabetes Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00695565 record still lists
NCT00695565 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (88% higher).
The record links to 1 condition, with Painful Diabetic Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo Gel is the first listed.
NCT00695565 lists 16 locations in 14 states (California, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT00695565 about?
NCT00695565 is a clinical study titled "Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy". The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
What is the current status of trial NCT00695565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2008-05. Estimated completion is 2010-02.
What conditions does trial NCT00695565 study?
This clinical trial studies the following conditions: Painful Diabetic Neuropathy.
What interventions are being tested in trial NCT00695565?
The interventions under investigation include: Placebo Gel (DRUG), Clonidine Topical Gel (ARC-4558) (DRUG).
Who is sponsoring clinical trial NCT00695565?
This trial is sponsored by Arcion Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00695565 being conducted?
This trial has 16 study locations across Alabama, California, Florida, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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