Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Public ClinicalTrials.gov record NCT02074007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subjects Aged 2 Months to 19 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The patient or caregiver will measure the amount of ear pain before and after the ear drops to establish if the medicated ear drops decrease the amount of pain more than the placebo ear drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be used up to 4 days, as needed for ear pain.
Study identification
- NCT ID
- NCT02074007
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 178 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Months to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2013 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jun 2014 (Actual)
- Last update posted
- Jan 24, 2017
2013 – 2014
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Consortium Arizona | Phoenix | Arizona | 85004 | — |
| Kern Allergy and Medical Research, Inc | Bakersfield | California | 93301 | — |
| Central California Research | Fresno | California | 93720 | — |
| Pharma Research International, Inc | Naples | Florida | 34102 | — |
| SCORE Physician Alliance, LLC | St. Petersburg | Florida | 33710 | — |
| Kentucky Pediatric / Adult Research | Bardstown | Kentucky | 40004 | — |
| Pioneer Clinical Research, LLC | Bellevue | Nebraska | 68005 | — |
| Omaha ENT Clinic | Omaha | Nebraska | 68130 | — |
| Children's Health Center / St. Elizabeth Medical Center | Utica | New York | 13502 | — |
| Valley Stream Pediatrics | Valley Stream | New York | 11580 | — |
| Haywood pediatric and Adolescent Medicine Group, PA | Clyde | North Carolina | 39721 | — |
| Sterling Research Group, LTD | Cinncinati | Ohio | 45246 | — |
| Central Ohio Clinical Research | Columbus | Ohio | 43207 | — |
| Urgent Care Specialists Hometown Urgent Care | Columbus | Ohio | 43214 | — |
| Carolina Ear, Nose & Throat Clinic | Orangeburg | South Carolina | 29118 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Heartland Research Associates LLC - Augusta | Salt Lake City | Utah | 84121 | — |
| Van Dorn Pediatrics | Alexandria | Virginia | 22302 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02074007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02074007 live on ClinicalTrials.gov.