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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: Completed Phase 2 study of Sickle Cell Anemia and Skin Ulcers, sponsored by Susan P. Perrine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally. Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry.
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 |
What the finished NCT00004412 record still lists
NCT00004412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 100-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00004412's enrollment target sits among peer trials
23 19th of 22 higher than 3 of 22 other Sickle Cell Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Anemia 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.
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