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NCT00662012 · ClinicalTrials.gov registry record · Phase 2
Sodium Stibogluconate Treatment of Leishmaniasis
A Phase 2 study of Leishmaniasis, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 2
- Development phase
- 414
- Enrollment target
- 1
- Study location
NCT00662012: Completed Phase 2 study of Leishmaniasis, sponsored by U.S. Army Medical Research and Development Command.
NCT00662012 is a Phase 2 study of Leishmaniasis that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 414 participants, above the 154-participant average among 3 other Leishmaniasis trials with a reported enrollment target (169% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00662012, a Phase 2 study of Leishmaniasis, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 414 participants
- Enrollment target
- 1
- Study location
Study Summary
Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).
Primary Outcome
The primary safety endpoint is the frequency of complications of therapy
Conditions Studied
Interventions
- DRUG Sodium Stibogluconate (SSG)
Study Locations (1)
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2002-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00662012 record still lists
NCT00662012 is an interventional study that assigns participants to a tested intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 3 other Leishmaniasis trials with a reported enrollment target (169% higher).
The record links to 1 condition, with Leishmaniasis appearing as the primary indexed condition, and to 1 intervention - of which Sodium Stibogluconate (SSG) is the first listed.
NCT00662012 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00662012 about?
NCT00662012 is a clinical study titled "Sodium Stibogluconate Treatment of Leishmaniasis". Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smit...
What is the current status of trial NCT00662012?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 414 participants. The study started on 2002-06. Estimated completion is 2007-12.
What conditions does trial NCT00662012 study?
This clinical trial studies the following conditions: Leishmaniasis.
What interventions are being tested in trial NCT00662012?
The interventions under investigation include: Sodium Stibogluconate (SSG) (DRUG).
Who is sponsoring clinical trial NCT00662012?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00662012 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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