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Sponsored by: |
Accentia Biopharmaceuticals |
Information provided by: | Accentia Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00425620 |
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.
Condition | Intervention | Phase |
Chronic Sinusitis |
Drug: SinuNase |
Phase III |
MedlinePlus related topics: | Sinusitis |
ChemIDplus related topics: | Amphotericin B |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS) |
Enrollment: | 300 |
Study Start Date: | December 2006 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
Amphotericin B: Experimental |
Drug: SinuNase
Lavage
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 68 Study Locations |
Accentia Biopharmaceuticals |
Study Director: | Angelos M Stergiou, MD | Accentia Biopharmaceuticals |
Responsible Party: | Accentia Biopharmaceuticals ( Ben McOmber, MPH ) |
Study ID Numbers: | ACC-05-01 |
First Received: | January 19, 2007 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00425620 |
Health Authority: | United States: Food and Drug Administration |
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