Trials / Completed
CompletedNCT00425620
Amphotericin B Suspension in Refractory Chronic Sinusitis
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Accentia Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SinuNase | Lavage |
Timeline
- Start date
- 2006-12-01
- Completion
- 2007-10-01
- First posted
- 2007-01-23
- Last updated
- 2007-11-30
Locations
68 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00425620. Inclusion in this directory is not an endorsement.