Clinical Trial Search

Primary: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment — 20; 9; 1; 2…

Primary: Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media — 26; 16; 12; 22 Ears — p=0.02

Primary: Number of Ears With Otorrhea (Drainage From the Middle Ear) — 8 affected ears

Primary: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear — 13; 27; 15; 23 participants

Primary: Number of Participants With Adverse Events — 48; 36 Participants

Primary: Incidence of Acute Otitis Media — 30; 27 participants with AOM

Primary: The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year — 1.48; 1.56 Occurrences per child-year — p=0.66

Primary: Number of Participants With Adverse Events — 2; 6 Participants

Primary: Number of Subjects With Adverse Events — 19; 14; 4 Participants

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 10; 3; 3 Participants

Primary: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) — -4.3; -5.0; -4.6; -4.9 units on a scale

Primary: Severity of Symptoms of Otitis Media — 2.0; 2.0 units on a scale

Primary: Resolution of Otitis Media Symptoms — 14.2; 16.5; 7.5; 14.1 units on a scale — p=.002

Primary: Number of Antibiotic Prescriptions — 140; 115; 6; 7 Emergency department encounters

Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants

Primary: Percentage of Participants Who Were Treatment Failures. — 21.3; 45.5 percentage of treatment failures

Primary: Percentage of Participants Who Were Treatment Failures — 24.6; 44.8 percentage of treatment failures

Primary: Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media — 66.9; 63.3 percentage of particpants — p=0.6

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 76.2; 71.8; 56.8 percentage of participants

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 77.1; 75.5; 65.3 percentage of participants

Primary: Number of Subjects Considered a Clinical Cure at Day 8 — 91; 63 Participants

Primary: Otoscopic Examination: Auricle and Meatus — 1 ears

Primary: The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product — 10; 30 Participants

Primary: Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear — 1; 0 participants

Primary: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) — 240; 304 Subjects

Primary: Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15) — 23; 3; 0 Participants

Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 71.7; 33.3 percentage of participants

Primary: Number and Type of Contacts With Health Care Providers — 45; 14; 5; 3 Participants

Primary: Device Success — 21 devices

Primary: Maximum Analyte Plasma Concentration (Cmax) — 2.44; 1.61 ng/mL