Trial · NCT02307916
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
NCT02307916, Phase 2, Completed, D. Bradley Welling, MD, PhD; results first posted 2020-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations. Trials, record NCT02307916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02307916
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
- NCT number
- NCT02307916
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- D. Bradley Welling, MD, PhD
- Conditions
- Tympanic Membrane Perforation
- Interventions
- FGF-2, Placebo
- First posted
- 2014-12-04
- Last updated
- 2025-12-08
- Results first posted
- 2020-06-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Tympanic Membrane Closure Following Treatment | ~60 days | 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. |
| Secondary | Measurement of Changes in Pure-tone Averages | Baseline, 60 days | measured by pre- and post-treatment audiograms. |
| Secondary | Measurement of Changes in Speech Discrimination Scores | Baseline, 60 days | Speech discrimination score is determined by having the patient listen to words through headphones and having the patient repeat the words back to the audiologist. A score of 100 percent (100%) is the best outcome, and 0 percent (0%) is the worst. Pre- and post- treatment tests are compared and analyzed. |
| Secondary | Number of Treatments Required for Closure of the Tympanic Membrane Perforation | 60 days | Out of the patients who healed, some healed with 1 treatment, some with 2 treatments, and some with 3 treatments. |
| Secondary | Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry | 60 days | Tympanometry is an examination used to test the condition of the middle ear and the mobility of the eardrum. Any type of perforation, regardless of size, would cause the result of the tympanometry to be abnormal. We use this test to determine if the eardrum closed completely. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Tympanic Membrane Closure Following Treatment | ~60 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Measurement of Changes in Pure-tone Averages | Baseline, 60 days | dB | MEAN | |
| SECONDARY | Measurement of Changes in Speech Discrimination Scores | Baseline, 60 days | percent | MEAN | |
| SECONDARY | Number of Treatments Required for Closure of the Tympanic Membrane Perforation | 60 days | treatments | MEAN | |
| SECONDARY | Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry | 60 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Tympanic Membrane Closure Following Treatment | FGF-2 | 23 | Participants | ||
| Number of Patients With Tympanic Membrane Closure Following Treatment | Placebo | 10 | Participants | ||
| Measurement of Changes in Pure-tone Averages | FGF-2 | 7.9 | Standard Deviation 8.8 | dB | |
| Measurement of Changes in Pure-tone Averages | Placebo | 5.9 | Standard Deviation 9.1 | dB | |
| Measurement of Changes in Speech Discrimination Scores | FGF-2 | 3.2 | Standard Deviation 8.1 | percent | |
| Measurement of Changes in Speech Discrimination Scores | Placebo | 1.7 | Standard Deviation 4.7 | percent | |
| Number of Treatments Required for Closure of the Tympanic Membrane Perforation | FGF-2 | 1.4 | Standard Deviation 0.6 | treatments | |
| Number of Treatments Required for Closure of the Tympanic Membrane Perforation | Placebo | 1.7 | Standard Deviation 0.6 | treatments | |
| Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry | FGF-2 | 23 | Participants | ||
| Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry | Placebo | 10 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FGF-2 | 42 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | FGF-2 | 40 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | FGF-2 | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear drainage post-treatment | Ear and labyrinth disorders | FGF-2 | 5 | 42 | 9 |
| other | Ear drainage post-treatment | Ear and labyrinth disorders | Placebo | 2 | 15 | 2 |
| other | Ear pain during procedure | Ear and labyrinth disorders | FGF-2 | 3 | 42 | 3 |
| other | Ear pain during procedure | Ear and labyrinth disorders | Placebo | 2 | 15 | 4 |
| other | Ear infection | Ear and labyrinth disorders | FGF-2 | 5 | 42 | 7 |
| other | Ear infection | Ear and labyrinth disorders | Placebo | 1 | 15 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FGF-2 | 0 | 42 |
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, other adverse events | FGF-2 | 13 | 42 |
| Total, other adverse events | Placebo | 5 | 15 |
| Total, serious adverse events | FGF-2 | 0 | 42 |
| Total, serious adverse events | Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FGF-2 vs Placebo: Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry | Trial comparisons |
| FGF-2 vs Placebo: Number of Patients With Tympanic Membrane Closure Following Treatment | Trial comparisons |
| FGF-2 vs Placebo: deaths from any cause | Trial comparisons |
| FGF-2 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02307916
GET https://conductscience.org/api/trials/v1/NCT02307916/registered