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Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

NCT00534625 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-03-21

No results posted yet for this study

Summary

A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.

Conditions

Interventions

DRUG

zileuton

Single injection of zileuton 150 mg

DRUG

placebo

Single injection of placebo

DRUG

zileuton

Single injection of zileuton 300 mg

Sponsors & Collaborators

  • Critical Therapeutics

    lead INDUSTRY

Principal Investigators

  • Dr. Cees Wortel · Critical Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-03-31
Completion
2008-03-31

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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 NCT00534625 on ClinicalTrials.gov