Phase 2
N=57
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Tympanic Membrane Perforation
Bottom Line
View on ClinicalTrials.gov: NCT02307916 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Patients With Tympanic Membrane Closure Following Treatment — 23; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FGF-2 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- D. Bradley Welling, MD, PhD
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Tympanic Membrane Closure Following Treatment |
23; 10 | — |
| SECONDARY Measurement of Changes in Pure-tone Averages |
7.9; 5.9 | — |
| SECONDARY Measurement of Changes in Speech Discrimination Scores |
3.2; 1.7 | — |
| SECONDARY Number of Treatments Required for Closure of the Tympanic Membrane Perforation |
1.4; 1.7 | — |
| SECONDARY Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry |
23; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Dry tympanic membrane perforation of greater than 3 months duration
- If female, post-menopausal or sterile, or if she is of child-bearing potential, must have a negative beta-human chorionic gonadotropin (HCG) test and must be using an adequate form of birth control such as birth control pills, birth control implants, intrauterine devices (IUDs), diaphragms or condoms.
Exclusion Criteria
The presence of any of the following excludes a subject from study enrollment:
- Active otitis media or chronic otorrhea from the middle ear
- Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy
- Subjects who, at study entry, are taking systemic antibiotics
- Subjects who are immunosuppressed
- Subjects experiencing bacterial or viral infection or who may otherwise be febrile
- Life expectancy of less than 1 year
- Active alcohol or drug abuse within 6 months prior to study entry
- Significant medical condition that could prevent full participation in the procedures required for the study (See body of protocol for full list of exclusions)
- Known or suspected allergies to any components used in the study
- Subjects who have cholesteatoma mass in the tympanic cavity
- Subjects whose total perforation cannot be seen by an endoscope
- Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher)
- Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility
Data sourced from ClinicalTrials.gov (NCT02307916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.