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NCT00279916 · ClinicalTrials.gov registry record · Phase 3
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
A Phase 3 study of Otitis Media With Effusion and Rhinitis, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
- 1
- Study location
NCT00279916: Completed Phase 3 study of Otitis Media With Effusion and Rhinitis, sponsored by Mayo Clinic.
NCT00279916 is a Phase 3 study of Otitis Media With Effusion and Rhinitis that has completed, run by Mayo Clinic. The registered enrollment target is 91 participants, below the 178-participant average among 5 other Otitis Media With Effusion trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00279916, a Phase 3 study of Otitis Media With Effusion and Rhinitis, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
- 1
- Study location
Study Summary
We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis media wit effusion in adults treated with placebo will be relatively low (minority of patients).
Primary Outcome
Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.
Conditions Studied
Interventions
- DRUG Placebo nasal spray
- DRUG Triamcinolone acetonide nasal spray
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2005-09-01 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00279916 record still lists
NCT00279916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 178-participant average among 5 other Otitis Media With Effusion trials with a reported enrollment target (49% lower).
The record links to 5 conditions, with Otitis Media With Effusion appearing as the primary indexed condition, and to 2 interventions - of which Placebo nasal spray is the first listed.
NCT00279916 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00279916 about?
NCT00279916 is a clinical study titled "Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays". We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis med...
What is the current status of trial NCT00279916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2005-09-01. Estimated completion is 2009-03.
What conditions does trial NCT00279916 study?
This clinical trial studies the following conditions: Otitis Media With Effusion, Rhinitis, Otitis Media, Serous, Negative Middle Ear Pressure, Otitis Media, Secretory.
What interventions are being tested in trial NCT00279916?
The interventions under investigation include: Placebo nasal spray (DRUG), Triamcinolone acetonide nasal spray (DRUG).
Who is sponsoring clinical trial NCT00279916?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00279916 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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