# A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

> **NCT03818815** · PHASE2 · COMPLETED · sponsor: **Novus Therapeutics, Inc** · enrollment: 103 (actual)

## Conditions studied

- Acute Otitis Media

## Interventions

- **COMBINATION_PRODUCT:** OP0201
- **COMBINATION_PRODUCT:** Placebo
- **DRUG:** Amoxicillin-clavulanate

## Key facts

- **NCT ID:** NCT03818815
- **Lead sponsor:** Novus Therapeutics, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-02-21
- **Primary completion:** 2020-03-09
- **Final completion:** 2020-03-26
- **Target enrollment:** 103 (ACTUAL)
- **Last updated:** 2020-08-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03818815

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03818815, "A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03818815. Licensed CC0.

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