NCT03116737 is a Phase 3 clinical trial of Benzocaine Otic Solution in Pain, sponsored by Lachlan Pharma Holdings.

Who is sponsoring NCT03116737?

NCT03116737 is sponsored by Lachlan Pharma Holdings.

What drugs are being tested in NCT03116737?

Interventions in NCT03116737: Benzocaine Otic Solution, Placebo.

What condition does NCT03116737 study?

NCT03116737 studies Pain, Acute Otitis Media.

Is NCT03116737 still recruiting?

NCT03116737 is currently completed. Last updated 13 October 2017.

Last reviewed 2017-10-13 · How we verify

NCT03116737

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 13 October 2017

What this trial tests

Phase 3 trial testing Benzocaine Otic Solution in Pain in 141 participants. Completed in 21 July 2017.

Timeline

3 January 2017

Primary endpoint
21 July 2017

21 July 2017

Quick facts

Lead sponsor	Lachlan Pharma Holdings
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	141
Start date	3 January 2017
Primary completion	21 July 2017
Estimated completion	21 July 2017
Sites	1 location across United States

Drugs / interventions tested

Benzocaine Otic Solution — full drug profile →
Placebo

Conditions studied

Pain — all drugs for Pain →
Acute Otitis Media — all drugs for Acute Otitis Media →

Sponsor

Lachlan Pharma Holdings — full company profile →

Who can join

Adults 5 to 12, any sex, with Pain or Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03116737 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lachlan Pharma Holdings
Last refreshed: 13 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03116737.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing