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NCT03116737 · ClinicalTrials.gov registry record · Phase 3

Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children

A Phase 3 study of Pain and Acute Otitis Media, sponsored by Lachlan Pharma Holdings.

Completed
Registry status
Phase 3
Development phase
141
Enrollment target
1
Study location

NCT03116737: Completed Phase 3 study of Pain and Acute Otitis Media, sponsored by Lachlan Pharma Holdings.

NCT03116737 is a Phase 3 study of Pain and Acute Otitis Media that has completed, run by Lachlan Pharma Holdings. The registered enrollment target is 141 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03116737, a Phase 3 study of Pain and Acute Otitis Media, has completed, sponsored by Lachlan Pharma Holdings.

COMPLETED
Registry status
Phase 3
Development phase
141 participants
Enrollment target
1
Study location

Study Summary

The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Benzocaine Otic Solution

Study Locations (1)

Oregon

  • Cyn3rgy Research - Gresham

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2017-01-03
Est. Completion 2017-07-21
Phase Phase 3
Lachlan Pharma Holdings

1 total trials

What the finished NCT03116737 record still lists

NCT03116737 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (54% lower).

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03116737 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT03116737 about?

NCT03116737 is a clinical study titled "Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children". The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.

What is the current status of trial NCT03116737?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2017-01-03. Estimated completion is 2017-07-21.

What conditions does trial NCT03116737 study?

This clinical trial studies the following conditions: Pain, Acute Otitis Media.

What interventions are being tested in trial NCT03116737?

The interventions under investigation include: Placebo (DRUG), Benzocaine Otic Solution (DRUG).

Who is sponsoring clinical trial NCT03116737?

This trial is sponsored by Lachlan Pharma Holdings, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03116737 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03116737's enrollment target sits among peer trials

141 122nd of 374 higher than 253 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03116737, the US trial registry maintained by the National Library of Medicine. NCT03116737 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.