Acute Otitis Media

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

AbbottABBOTT PARK, IL

3 programs

cefdinirPhase 41 trial

cefdinirPhase 2/31 trial

Active Trials

NCT00645203Completed447

NCT00645112Completed357

NCT00644943Completed425

Sharp TherapeuticsPA - Pittsburgh

1 program

MontelukastPhase 4

MSDIreland - Ballydine

1 program

MontelukastPhase 4

AlconFORT WORTH, TX

6 programs

Moxidex otic solutionPhase 31 trial

AL-60371/AL-817 otic suspensionPhase 21 trial

Moxidex otic solutionPhase 21 trial

+1 more programs

Active Trials

NCT01027494Completed318Est. Nov 2012

NCT01908803Terminated84Est. Aug 2014

NCT00578773Completed303Est. Jan 2009

+3 more trials

Allergy TherapeuticsUK - West Sussex

1 program

Amoxicillin-Clavulanate, 10 daysPhase 21 trial

Active Trials

NCT01511107Terminated520Est. Oct 2015

Currax PharmaceuticalsTN - Brentwood

1 program

Antipyrine and Benzocaine otic solutionPhase 21 trial

Active Trials

NCT02037893Completed112Est. Sep 2014

ViiV HealthcareNC - Durham

4 programs

Data collectionN/A

Middle ear fluid, nasopharyngeal aspirate and urine sample.N/A

Sample CollectionN/A

GSKLONDON, United Kingdom

4 programs

Data collectionN/A1 trial

Middle ear fluid, nasopharyngeal aspirate and urine sample.N/A1 trial

Sample CollectionN/A1 trial

Active Trials

NCT02567747Completed1Est. Feb 2018

NCT02742753Completed1Est. Sep 2017

NCT01031082Completed265Est. May 2010

+1 more trials

SalvatFL - Miami

2 programs

DF289PHASE_31 trial

Active Trials

NCT01404611Completed331Est. Jun 2013

NCT01395966Completed331Est. Jun 2014

Integra LifeSciencesAustralia - Clayton

1 program

Iontophoresis SystemN/A1 trial

Active Trials

NCT00941993Completed109Est. Jan 2011

RecordatiFrance - Saint-Victor

1 program

Lactobacillus salivarius PS7 during 6 monthsN/A1 trial

Active Trials

NCT03614117Completed222Est. Jul 2020

Merck & Co.RAHWAY, NJ

1 program

MontelukastPHASE_45 trials

Active Trials

NCT01618929Completed113Est. May 2016

NCT01621386Completed34Est. Mar 2016

NCT01404013Unknown99Est. Aug 2014

+2 more trials

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Merck & Co.Montelukast

Abbottcefdinir

SalvatDF289

AlconMoxidex otic solution

Merck & Co.Montelukast

Showing 15 of 36 trials with date data

Clinical Trials (36)

Total enrollment: 7,152 patients across 36 trials

NCT01618929 Merck & Co.Montelukast

Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Start: Mar 2013Est. completion: May 2016113 patients

Phase 4Completed

NCT01404013 Merck & Co.Montelukast

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

Start: Feb 2012Est. completion: Aug 201499 patients

Phase 4Unknown

NCT01027806 Merck & Co.Montelukast

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Start: Jul 2010Est. completion: Aug 201464 patients

Phase 4Terminated

NCT00559546 Merck & Co.Montelukast

Montelukast as a Controller of Atopic Syndrome

Start: Mar 2007Est. completion: Jul 200761 patients

Phase 4Completed

NCT00721240 Merck & Co.Montelukast

Investigation to Identify Predictors of Response to a Treatment With Montelukast

Start: Feb 2006Est. completion: Jun 200950 patients

Phase 4Completed

NCT00934713 Merck & Co.Montelukast

The Effect of Montelukast Treatment in Wheezy Infants

Start: Sep 2004Est. completion: Apr 2008112 patients

Phase 4Completed

NCT00189462 Merck & Co.Montelukast

A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Start: Mar 2004Est. completion: Dec 200599 patients

Phase 4Completed

NCT00645112 Abbottcefdinir

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Start: Nov 2003357 patients

Phase 4Completed

NCT00644943 Abbottcefdinir

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Start: Feb 2003425 patients

Phase 4Completed

NCT01395966 SalvatDF289

Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start: Jun 2011Est. completion: Jun 2014331 patients

Phase 3Completed

NCT01404611 SalvatDF289

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start: Jun 2011Est. completion: Jun 2013331 patients

Phase 3Completed

NCT01071902 AlconMoxidex otic solution

Safety and Efficacy of Moxidex Otic

Start: Feb 2010Est. completion: Oct 2011400 patients

Phase 3Terminated

NCT00579189 AlconMoxidex otic solution

Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Start: Jan 2006Est. completion: Jan 2009776 patients

Phase 3Completed

NCT00578474 AlconMoxidex otic solution

A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Start: Dec 2005Est. completion: Aug 2008911 patients

Phase 3Completed

NCT00116324 Merck & Co.Montelukast

Predicting the Response to Montelukast by Genetic Variation in Asthmatics

Start: Apr 2003Est. completion: Dec 2006150 patients

Phase 3Completed

NCT00162864 Merck & Co.Montelukast

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

Start: Dec 1999Est. completion: Apr 2002200 patients

Phase 3Completed

NCT00645203 Abbottcefdinir

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Start: Jul 2002447 patients

Phase 2/3Completed

NCT01908803 AlconAL-60371/AL-817 otic suspension

Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

Start: Dec 2013Est. completion: Aug 201484 patients

Phase 2Terminated

NCT02037893 Currax PharmaceuticalsAntipyrine and Benzocaine otic solution

Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media

Start: Nov 2013Est. completion: Sep 2014112 patients

Phase 2Completed

NCT01511107 Allergy TherapeuticsAmoxicillin-Clavulanate, 10 days

Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance

Start: Jan 2012Est. completion: Oct 2015520 patients

Phase 2Terminated

NCT00578773 AlconMoxidex otic solution

A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Start: Nov 2007Est. completion: Jan 2009303 patients

Phase 2Completed

NCT00213252 Merck & Co.Montelukast

Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

Start: Sep 2005Est. completion: Feb 2008130 patients

Phase 2Completed

NCT01621386 Merck & Co.Montelukast

Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Start: Jan 2013Est. completion: Mar 201634 patients

Phase 1Completed

NCT01086527 Merck & Co.Montelukast

Genotype Stratified Pharmacokinetic Study of Montelukast

Start: Mar 2010Est. completion: Dec 20142 patients

Phase 1Completed

NCT00492102 Merck & Co.Montelukast

Montelukast in Very Low Birthweight Infants

Start: Mar 2007Est. completion: Jun 20119 patients

Phase 1Completed

NCT03614117 RecordatiLactobacillus salivarius PS7 during 6 months

Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)

Start: Oct 2018Est. completion: Jul 2020222 patients

N/ACompleted

NCT02742753 GSKData collection

Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children

Start: Jun 2016Est. completion: Sep 20171 patients

N/ACompleted

NCT02567747 GSKData collection

Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age

Start: Oct 2015Est. completion: Feb 20181 patients

N/ACompleted

NCT01230437 Merck & Co.Montelukast

Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis

Start: Jan 2011Est. completion: Dec 201140 patients

N/AUnknown

NCT01072227 GSKSample Collection

Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan

Start: Jul 2010Est. completion: Apr 201110 patients

N/ATerminated

NCT01027494 AlconCiprofloxacin 0.3% and dexamethasone 0.1% otic suspension

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

Start: Dec 2009Est. completion: Nov 2012318 patients

N/ACompleted

NCT01031082 GSKMiddle ear fluid, nasopharyngeal aspirate and urine sample.

Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children

Start: May 2009Est. completion: May 2010265 patients

N/ACompleted

NCT00710450 Merck & Co.Montelukast

Effect of Montelukast on Basophils, In-vitro

Start: May 2008Est. completion: Sep 201115 patients

N/AUnknown

NCT00941993 Integra LifeSciencesIontophoresis System

Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus

Start: Apr 2008Est. completion: Jan 2011109 patients

N/ACompleted

NCT00513760 Merck & Co.Montelukast

Transporter Mediated Uptake of Montelukast

Start: Jun 2007Est. completion: Dec 201427 patients

N/ACompleted

NCT00148603 Merck & Co.Montelukast

Montelukast in the Treatment of Duodenal Eosinophilia

Start: Sep 2005Est. completion: Dec 200624 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals

13 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.