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NCT00004412 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
A Phase 2 study of Sickle Cell Anemia and Skin Ulcers, sponsored by Susan P. Perrine.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT00004412 is a Phase 2 study of Sickle Cell Anemia and Skin Ulcers that has completed, run by Susan P. Perrine. The registered enrollment target is 23 participants, below the 100-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT00004412, a Phase 2 study of Sickle Cell Anemia and Skin Ulcers, has completed, sponsored by Susan P. Perrine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
Conditions Studied
Interventions
- DRUG Arginine Butyrate
- OTHER Standard local care dressing
Study Locations (4)
Illinois
- University of Illinois College of Medicine - Chicago
Massachusetts
- Boston University School of Medicine - Boston
New York
- Mount Sinai School of Medicine - New York
Tennessee
- University of Tennessee, Memphis Cancer Center - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 1997-09 |
| Est. Completion | 2005-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004412
The ClinicalTrials.gov registry entry for NCT00004412 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (77% lower). The listed sponsor is Susan P. Perrine, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sickle Cell Anemia appearing as the primary indexed condition, and to 2 interventions - of which Arginine Butyrate is the first listed.
NCT00004412 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Illinois, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT00004412 about?
NCT00004412 is a clinical study titled "Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers". OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these ...
What is the current status of trial NCT00004412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 1997-09. Estimated completion is 2005-02.
What conditions does trial NCT00004412 study?
This clinical trial studies the following conditions: Sickle Cell Anemia, Skin Ulcers.
What interventions are being tested in trial NCT00004412?
The interventions under investigation include: Arginine Butyrate (DRUG), Standard local care dressing (OTHER).
Who is sponsoring clinical trial NCT00004412?
This trial is sponsored by Susan P. Perrine, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004412 being conducted?
This trial has 4 study locations across Illinois, Massachusetts, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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