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NCT00101361 · ClinicalTrials.gov registry record · Phase 3
Oxandrolone to Heal Pressure Ulcers
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT00101361 is a Phase 3 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 212 participants.
The verdict
NCT00101361, a Phase 3 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other sites will screen patients to determine eligibility but will not treat patients with the agent. Following the Feasibility Study, all sites will participate in a blinded, randomized treatment study. A total of 400 patients will be enrolled over a four-year period. Any patient in a participating unit who has chronic SCI and a difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are met. All enrolled patients will be followed for a period of 24 weeks to determine whether their target pressure ulcers heal. Those who are healed will be followed for an additional four weeks to determine whether the ulcer remains healed.
Interventions
- DRUG Placebo
- DRUG Oxandrolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00101361
The ClinicalTrials.gov registry entry for NCT00101361 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00101361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00101361 about?
NCT00101361 is a clinical study titled "Oxandrolone to Heal Pressure Ulcers". This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other site...
What is the current status of trial NCT00101361?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2005-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00101361?
The interventions under investigation include: Placebo (DRUG), Oxandrolone (DRUG).
Who is sponsoring clinical trial NCT00101361?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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