Comparison · NCT02307916-caed0ef4
FGF-2 vs Placebo: Number of Patients With Tympanic Membrane Closure Following Treatment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FGF-2 vs Placebo: Number of Patients With Tympanic Membrane Closure Following Treatment. Trial comparisons, record NCT02307916-caed0ef4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02307916-caed0ef4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.575 | 0.422 | 0.715 | wilson | |
| Risk in group 2 | 0.714 | 0.454 | 0.883 | wilson | |
| Risk difference, group 1 minus group 2 | -0.139 | -0.367 | 0.157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.805 | 0.526 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.541 | 0.145 | 2.02 | log | |
| Number needed to treat, for one fewer participant with the outcome on FGF-2 than on Placebo | 7.18 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FGF-2 | FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~FGF-2: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery. | 23 | 40 | OG000 |
| Group 2 | Placebo | Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~Placebo: Placebo comparator using a sterile saline solution. | 10 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Tympanic Membrane Closure Following Treatment
- Description
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.
- Time frame
- ~60 days
- Population
Source ClinicalTrials.gov
Trial
- Title
- Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
- NCT number
- NCT02307916
- Phases
- PHASE2
- Conditions
- Tympanic Membrane Perforation
- Interventions
- FGF-2, Placebo
- Lead sponsor
- D. Bradley Welling, MD, PhD
- Results first posted
- 2020-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02307916?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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