Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Public ClinicalTrials.gov record NCT02044341. 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
- NCT02044341
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 304 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
- Mar 2014 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Apr 8, 2015
2013 – 2014
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shoals Medical Trials, Inc. | Sheffield | Alabama | 35660 | — |
| SC Clinical Research, Inc | Tuscon | Arizona | 85745 | — |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| So Cal Clinical Research Group | Bellflower | California | 90706 | — |
| Southland Clinical Research Center | Fountain Valley | California | 92708 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Colorado Springs Health Partners /Clinical Research Advantag | Colorado Springs | Colorado | 80902 | — |
| Pharma Research International, Inc | Naples | Florida | 34102 | — |
| SCORE Physician Alliance, LLC | St. Petersburg | Florida | 33710 | — |
| The Iowa Clinic, Pc | West Des Moines | Iowa | 50266 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | — |
| Kentucky Pediatric / Adult Research | Bardstown | Kentucky | 40004 | — |
| Brownsboro Park Pediatrics | Louisville | Kentucky | 40207 | — |
| Michael W. Simon, MD, PSC | Nicholasville | Kentucky | 40356 | — |
| Virgo-Carter Pediatrics | Silver Spring | Maryland | 20910 | — |
| Hennepin County Medical Center -Department of Emergency Medicine | Minneapolis | Minnesota | 55415 | — |
| Clinical Research Center | Las Vegas | Nevada | 89104 | — |
| Valley Stream Pediatrics | Valley Stream | New York | 11580 | — |
| White Oak Family Physicians | Asheboro | North Carolina | 27203 | — |
| UNC Children's Hospital - General Pediatrics and Adolescent Medicine | Chapel Hill | North Carolina | 27516 | — |
| Hometown Urgent Care and Research Center (Dayton) | Dayton | Ohio | 45425 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| DiscoveResearch, Inc. | Byran | Texas | 77802 | — |
| Research Across America - Dallas | Dallas | Texas | 75234 | — |
| Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | 77375 | — |
| J. Lewis Research, Inc/Jordan River Family Medicine | Jordan | Utah | 84095 | — |
| FirstMed | Salt Lake City | Utah | 84109 | — |
| Lewis Research, Inc/Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| Wee Care Pediatrics | Syracuse | Utah | 84075 | — |
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 NCT02044341, 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 Apr 8, 2015 · 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 NCT02044341 live on ClinicalTrials.gov.