CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Drug: OP0201 20mg +1 morecombination
Likely dose
Drug: OP0201 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03766373
NCT03766373Phase 1Completed
CompareCT.gov

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media

Novus Therapeutics, Inc·interventional·Posted Dec 6, 2018·Updated Dec 5, 2019

In Brief

A Phase 1 clinical trial evaluating Drug: OP0201 20mg and Drug: Placebo 0mg for Acute Otitis Media. Completed, enrolled 24 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 6, 2018
Enrollment StartJan 7, 2019
Primary CompletionJan 30, 2019
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 7.6 years ago

Interventions

Drug: OP0201 20mgcombination

OP0201

Drug: Placebo 0mgcombination

Placebo