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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: Completed Phase 4 study, sponsored by Mt. Sinai Medical Center, Miami.

NCT00158041 is a Phase 4 study that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 452 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 452 participants
Start Date 2002-01
Est. Completion 2005-01
Phase Phase 4
Mt. Sinai Medical Center, Miami

13 total trials

What the finished NCT00158041 record still lists

NCT00158041 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 1 intervention - of which Amifostine administered subcutaneously is the first listed.

NCT00158041 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00158041's enrollment target sits among peer trials

452 187th of 2000 higher than 1,814 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00158041, the US trial registry maintained by the National Library of Medicine. NCT00158041 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.