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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 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 52 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04960384
The ClinicalTrials.gov registry entry for NCT04960384 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04960384 reports 0 study locations.
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.
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