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NCT04960384 · ClinicalTrials.gov registry record · Phase 2
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04960384: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT04960384 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04960384, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.
Primary Outcome
Determined by otoscopic exam and photographic documentation
Interventions
- DRUG Placebo
- DRUG FGF-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2025-10-27 |
| Phase | Phase 2 |
What the finished NCT04960384 record still lists
NCT04960384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04960384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04960384 about?
NCT04960384 is a clinical study titled "Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations". This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area...
What is the current status of trial NCT04960384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2022-05-27. Estimated completion is 2025-10-27.
What interventions are being tested in trial NCT04960384?
The interventions under investigation include: Placebo (DRUG), FGF-2 (DRUG).
Who is sponsoring clinical trial NCT04960384?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04960384's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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