MedTrace Logo

Subcutaneous Amifostine Safety Study

NCT00158041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2005-09-12

No results posted yet for this 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.

Conditions

Interventions

DRUG

Amifostine administered subcutaneously

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Michael A Samuels, MD · Mt. Sinai Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2005-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158041 on ClinicalTrials.gov