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NCT02307916 · ClinicalTrials.gov registry record · Phase 2
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
A Phase 2 study of Tympanic Membrane Perforation, sponsored by D. Bradley Welling, MD, PhD.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 2
- Study locations
NCT02307916: Completed Phase 2 study of Tympanic Membrane Perforation, sponsored by D. Bradley Welling, MD, PhD.
NCT02307916 is a Phase 2 study of Tympanic Membrane Perforation that has completed, run by D. Bradley Welling, MD, PhD. The registered enrollment target is 57 participants, below the 151-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02307916, a Phase 2 study of Tympanic Membrane Perforation, has completed, sponsored by D. Bradley Welling, MD, PhD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.
Primary Outcome
The efficacy of the treatment is determined by the number of patients whose tympanic membrane perforations closed after study treatments. Subjects from both treatment arms received up to three treatments before determining non-closure of the tympanic membrane.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG FGF-2
Study Locations (2)
Massachusetts
- Massachusetts Eye and Ear - Boston
Texas
- Wilford Hall, Lackland Airforce Base - Lackland City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-10 |
| Est. Completion | 2020-03 |
| Phase | Phase 2 |
What the finished NCT02307916 record still lists
NCT02307916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 151-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Tympanic Membrane Perforation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02307916 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT02307916 about?
NCT02307916 is a clinical study titled "Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations". A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is...
What is the current status of trial NCT02307916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2016-10. Estimated completion is 2020-03.
What conditions does trial NCT02307916 study?
This clinical trial studies the following conditions: Tympanic Membrane Perforation.
What interventions are being tested in trial NCT02307916?
The interventions under investigation include: Placebo (OTHER), FGF-2 (DRUG).
Who is sponsoring clinical trial NCT02307916?
This trial is sponsored by D. Bradley Welling, MD, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02307916 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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