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NCT01988779 · ClinicalTrials.gov registry record · Phase 3
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
A Phase 3 study of Chronic Rhinosinusitis, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01988779: Completed Phase 3 study of Chronic Rhinosinusitis, sponsored by University of Rochester.
NCT01988779 is a Phase 3 study of Chronic Rhinosinusitis that has completed, run by University of Rochester. The registered enrollment target is 33 participants, below the 182-participant average among 4 other Chronic Rhinosinusitis trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01988779, a Phase 3 study of Chronic Rhinosinusitis, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.
Primary Outcome
The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement
Conditions Studied
Interventions
- DRUG oral levofloxacin
- DRUG nebulized levofloxacin
Study Locations (1)
New York
- University of Rochester Department of Otolaryngology Head and Neck Surgery - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 3 |
What the finished NCT01988779 record still lists
NCT01988779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 182-participant average among 4 other Chronic Rhinosinusitis trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Chronic Rhinosinusitis appearing as the primary indexed condition, and to 2 interventions - of which oral levofloxacin is the first listed.
NCT01988779 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01988779 about?
NCT01988779 is a clinical study titled "Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations". The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intr...
What is the current status of trial NCT01988779?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2013-10. Estimated completion is 2020-12-31.
What conditions does trial NCT01988779 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis.
What interventions are being tested in trial NCT01988779?
The interventions under investigation include: oral levofloxacin (DRUG), nebulized levofloxacin (DRUG).
Who is sponsoring clinical trial NCT01988779?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01988779 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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