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NCT00884377 · ClinicalTrials.gov registry record · Phase 2
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
A Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00884377: Completed Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
NCT00884377 is a Phase 2 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00884377, a Phase 2 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
Primary Outcome
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In additi
Interventions
- DRUG Sodium stibogluconate (Pentostam)
- DEVICE ThermoMed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2004-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00884377 record still lists
NCT00884377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Sodium stibogluconate (Pentostam) is the first listed.
NCT00884377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00884377 about?
NCT00884377 is a clinical study titled "Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis". This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
What is the current status of trial NCT00884377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2004-02. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00884377?
The interventions under investigation include: Sodium stibogluconate (Pentostam) (DRUG), ThermoMed (DEVICE).
Who is sponsoring clinical trial NCT00884377?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00884377's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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