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COMPLETED Phase 2

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

NCT02307916 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 57 participants
Start Date 2016-10
Est. Completion 2020-03
Phase Phase 2

Sponsor

D. Bradley Welling, MD, PhD

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02307916

The ClinicalTrials.gov registry entry for NCT02307916 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is D. Bradley Welling, MD, PhD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02307916 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02307916?

The interventions under investigation include: Placebo (OTHER), FGF-2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02307916?

This trial is sponsored by D. Bradley Welling, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial