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Amphotericin B Suspension in Refractory Chronic Sinusitis

NCT00425620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2007-11-30

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.

Conditions

  • Chronic Sinusitis

Interventions

DRUG

SinuNase

Lavage

Sponsors & Collaborators

  • Accentia Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Angelos M Stergiou, MD · Accentia Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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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 NCT00425620 on ClinicalTrials.gov