Trial · NCT03116737
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
NCT03116737, Phase 3, Completed, Lachlan Pharma Holdings
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children. Trials, record NCT03116737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03116737
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
- NCT number
- NCT03116737
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 141 participants, actual
- Lead sponsor
- Lachlan Pharma Holdings
- Conditions
- Pain, Acute Otitis Media
- Interventions
- Benzocaine Otic Solution, Placebo
- First posted
- 2017-04-17
- Last updated
- 2017-10-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) | 60 minutes | |
| Secondary | Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) | 120 minutes | |
| Secondary | Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) | Up to 3 days | |
| Secondary | Dosing Intervals | Up to 3 days | |
| Secondary | Use of Rescue Medications | Up to 3 days | |
| Secondary | Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events | Up to 3 days | Safety will be assessed by adverse event reporting on all study days. Fisher's exact test will be used to compare adverse event rates between treatment groups for the following categories: 1) all adverse events; 2) treatment related adverse events; 3) severe adverse events; 4) serious adverse events; 5) discontinuation due to adverse event. |
| Secondary | Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations | Up to 3 days | Physical examinations will be assessed. For each body system of the physical examination, the shift from normal/abnormal will be presented by treatment group as the number and percentage of children. |
| Secondary | Assess the Safety and Tolerability of Benzocaine Based on Vital Signs | Up to 3 days | Vital signs (blood pressure, pulse, temperature, and respiratory rate) will be assessed. Descriptive statistics will be presented for the vital signs measurements collected, as well as the vital sign changes from Day 1 to Day 3 by treatment group. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03116737
GET https://conductscience.org/api/trials/v1/NCT03116737/registered