19 completed. 19 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 19 | Completed 19 |
Follow Otitis: new trials by email Literature Review of Otitis trials Research Report on Otitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial Omega-3-based nutraceutical combination (Otoair Flogo), Bilastine 20 mg, Placebo Tablet or Capsule - Otits Media With Effusion | Phase 4 | Completed | Isola Tiberina - Gemelli Isola Hospital, Rome, Italy | 501 | 2025-10-01 | 2026-07-23 |
| Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study) Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Saccharomyces boulardii CNCM I-745 - Antibiotic Associated Diarrhea, Acute Otitis Media | Phase 4 | Completed | Eskisehir Osmangazi University | 100 | 2025-08-01 | 2026-09-11 |
| Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India Augmentin (ES)-600 - Otitis Media, Infections, Respiratory Tract | Phase 4 | Completed | GlaxoSmithKline | 310 | 2022-05-07 | 2024-06-10 |
| Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion Mometasone 50 Mcg/Inh Nasal Spray, Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%), Steroid Drug (prednisolone) - Otitis Media With Effusion | Phase 4 | Completed | Lumbini Medical College | 160 | 2018-09-05 | 2020-06-19 |
| Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children Amoxicillin, Amoxicillin-Potassium Clavulanate, Macrolide - Acute Otitis Media | Phase 4 | Completed | University of Oulu | 73 | 2016-11-01 | 2022-08-11 |
| Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life Prevenar13, Synflorix - Otitis Media, Febrile Illness | Phase 4 | Completed | Menzies School of Health Research | 261 | 2013-03-12 | 2020-03-25 |
| Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics) Antibiotic prescription strategies - Rhinosinusitis, Acute Bronchitis | Phase 4 | Completed | Asociacion Colaboracion Cochrane Iberoamericana | 450 | 2012-06-01 | 2017-07-31 |
| Pneumococcal Vaccines Early and in Combination Synflorix, Prevenar13, COMBO - Otitis Media | Phase 4 | Completed | Menzies School of Health Research | 425 | 2011-08-01 | 2018-10-18 |
| Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children Lansoprazole, Placebo - Otitis Media With Effusion | Phase 4 | Completed | Hamilton Health Sciences Corporation | 65 | 2010-03-01 | 2015-04-14 |
| Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal drops intilation (Taponoto ® ), drops intilation (Otocerum®), drops intilation (Placebo) - Ear Infection, Hearing Loss | Phase 4 | Completed | Hospital Clinic of Barcelona | 90 | 2008-09-01 | 2008-10-03 |
| Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy Intranasal fentanyl, morphine IM, IV morphine - Otitis Media | Phase 4 | Completed | Baylor College of Medicine | 171 | 2008-05-01 | 2016-03-03 |
| Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age oseltamivir, placebo - Influenza | Phase 4 | Completed | Hospital District of Southwestern Finland | 409 | 2008-02-01 | 2009-06-19 |
| Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®) dornase alfa (Pulmozyme®) - Otitis Media | Phase 4 | Completed | University of Colorado, Denver | 41 | 2007-01-01 | 2026-06-08 |
| Acute Otitis Media (AOM) Therapy Trial in Young Children amoxicillin-clavulanate, Placebo - Acute Otitis Media | Phase 4 | Completed | University of Pittsburgh | 291 | 2006-11-01 | 2016-12-05 |
| Dexmedetomidine vs Fentanyl for BMT Saline, Fentanyl, Dexmedetomidine - Otitis | Phase 4 | Completed | Children's National Research Institute | 101 | 2005-08-01 | 2011-04-25 |
| A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children Montelukast, Placebo - Acute Otitis Media, Otitis Media | Phase 4 | Completed | Deborah Gentile | 99 | 2004-03-01 | 2020-11-18 |
| A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media cefdinir (Omnicef), azithromycin - Acute Otitis Media | Phase 4 | Completed | Abbott | 357 | 2003-11-01 | 2008-03-27 |
| A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media cefdinir (Omnicef), amoxicillin - Acute Otitis Media | Phase 4 | Completed | Abbott | 425 | 2003-02-01 | 2008-03-27 |
| Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children Amoxycillin, Placebo equivalent to amoxycillin - Otitis Media | Phase 4 | Completed | Menzies School of Health Research | 126 | 1996-04-01 | 2010-05-24 |
Otitis Media (14) · Otitis Media with Effusion (4) · Hearing Loss (2) · Respiratory Tract Infections (2) · Bronchitis (1) · Cough (1) · Hearing Loss, Conductive (1) · Influenza, Human (1) · Personal Satisfaction (1) · Rhinosinusitis (1) · Tympanic Membrane Perforation (1) · Vertigo (1)
Ear Diseases (19) · Otorhinolaryngologic Diseases (19) · Infections (4) · Respiratory Tract Diseases (4) · Otitis Media (3) · Pathological Conditions, Signs and Symptoms (3) · Signs and Symptoms (3) · Hearing Disorders (2) · Nervous System Diseases (2) · Neurologic Manifestations (2) · Respiratory Tract Infections (2) · Sensation Disorders (2) · Behavior (1) · Bronchial Diseases (1)
Amoxicillin-Potassium Clavulanate Combination (4) · Amoxicillin (3) · 13-valent pneumococcal vaccine (2) · Cefdinir (2) · Mometasone Furoate (2) · PHiD-CV vaccine (2) · Adrenal Cortex Hormones (1) · Anti-Bacterial Agents (1) · Azithromycin (1) · Capsules (1) · Dexmedetomidine (1) · Fatty Acids, Omega-3 (1) · Fentanyl (1) · Histamine Antagonists (1) · Lansoprazole (1)
Menzies School of Health Research (3) · Abbott (2) · Asociacion Colaboracion Cochrane Iberoamericana (1) · Baylor College of Medicine (1) · Children's National Research Institute (1) · Deborah Gentile (1) · Eskisehir Osmangazi University (1) · GlaxoSmithKline (1) · Hamilton Health Sciences Corporation (1) · Hospital Clinic of Barcelona (1) · Hospital District of Southwestern Finland (1) · Isola Tiberina - Gemelli Isola Hospital, Rome, Italy (1) · Lumbini Medical College (1) · University of Colorado, Denver (1) · University of Oulu (1)
United States (7) · Australia (3) · Finland (2) · Spain (2) · Canada (1) · India (1) · Italy (1) · Nepal (1) · Turkey (Türkiye) (1)
Amanda J Leach, PhD (2) · Alejandro Hoberman, MD (1) · David Skoner, MD (1) · Dr. Diane Reid, MD FRCSC (1) · Dr. Gavin Rukholm, MD (1) · Helena Karlberg, MD (1) · John D Mathews, PhD, DSc. (1) · Julia C Finkel, MD (1) · Kenny H Chan, MD (1) · Pablo Alonso Coello, PhD (1) · Terho J Heikkinen, MD (1)
PMID 35772449, PMID 38829821, PMID 12384383, PMID 20815736, PMID 21098526, PMID 21106443, PMID 21226576, PMID 22669347, PMID 25596202, PMID 30073253, PMID 32448790, PMID 33685411, PMID 37171965, PMID 37784098, PMID 37870130, PMID 38088821, PMID 42572144
U01AI066007 (1)