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NCT00158041 · ClinicalTrials.gov registry record · Phase 4
Subcutaneous Amifostine Safety Study
A Phase 4 study, sponsored by Mt. Sinai Medical Center, Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 452
- Enrollment target
NCT00158041 is a Phase 4 study that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 452 participants.
The verdict
NCT00158041, a Phase 4 study, has completed, sponsored by Mt. Sinai Medical Center, Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 452 participants
- Enrollment target
Study Summary
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.
Interventions
- DRUG Amifostine administered subcutaneously
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158041
The ClinicalTrials.gov registry entry for NCT00158041 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mt. Sinai Medical Center, Miami, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amifostine administered subcutaneously is the first listed.
NCT00158041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00158041 about?
NCT00158041 is a clinical study titled "Subcutaneous Amifostine Safety Study". Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized...
What is the current status of trial NCT00158041?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 452 participants. The study started on 2002-01. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00158041?
The interventions under investigation include: Amifostine administered subcutaneously (DRUG).
Who is sponsoring clinical trial NCT00158041?
This trial is sponsored by Mt. Sinai Medical Center, Miami, which has 13 total clinical trials registered on ClinicalTrials.gov.
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