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NCT00657618 · ClinicalTrials.gov registry record · Phase 1
Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
A Phase 1 study of Leishmaniasis, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT00657618: Completed Phase 1 study of Leishmaniasis, sponsored by U.S. Army Medical Research and Development Command.
NCT00657618 is a Phase 1 study of Leishmaniasis that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 77 participants, below the 266-participant average among 3 other Leishmaniasis trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657618, a Phase 1 study of Leishmaniasis, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 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 visceral 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 primary objective of this protocol is to collect safety data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days. Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details and safety assessments were recorded in the patients' medical records (study file) only. No data entry or statistical analyses of patient data was conducted.
Primary Outcome
The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen \[BUN\], creatinine, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], total bilirubin, alkaline phosphatase \[ALK\], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; elec
Conditions Studied
Interventions
- DRUG Sodium Stibogluconate (SSG)
Study Locations (1)
District of Columbia
- Walter Reed National Military Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2004-10 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT00657618 record still lists
NCT00657618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 266-participant average among 3 other Leishmaniasis trials with a reported enrollment target (71% lower).
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.
NCT00657618 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00657618 about?
NCT00657618 is a clinical study titled "Use of Sodium Stibogluconate as a Treatment for 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 NCT00657618?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2004-10. Estimated completion is 2015-04.
What conditions does trial NCT00657618 study?
This clinical trial studies the following conditions: Leishmaniasis.
What interventions are being tested in trial NCT00657618?
The interventions under investigation include: Sodium Stibogluconate (SSG) (DRUG).
Who is sponsoring clinical trial NCT00657618?
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 NCT00657618 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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