Trial Profile

A Phase II study of OP-02 for treatment and prevention of chronic otitis media with effusion (COME) in children

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 05 Nov 2019

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At a glance

Drugs Cholesteryl palmitate/colfosceril palmitate (Primary)
Indications Otitis media
Focus Adverse reactions; Therapeutic Use

Most Recent Events

29 Oct 2019 According to a Novus Therapeutics media release, the U.S. Food and Drug Administration (FDA) has agreed with the Company's proposed patient population, endpoints, and statistical analysis plan for this study in patients with chronic otitis media with effusion.
13 Aug 2019 According to a Novus Therapeutics media release, the company anticipates meeting with FDA to discuss the trial in September 2019.
16 Sep 2018 New trial record

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