Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media

PHASE3CompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Acute Otitis Media
Interventions
DRUG

AR01

drops administered an needed for pain

DRUG

Glycerin ear drops

placebo drops administered for ear pain

Trial Locations (29)

11580

Valley Stream Pediatrics, Valley Stream

20910

Virgo-Carter Pediatrics, Silver Spring

27203

White Oak Family Physicians, Asheboro

27516

UNC Children's Hospital - General Pediatrics and Adolescent Medicine, Chapel Hill

33710

SCORE Physician Alliance, LLC, St. Petersburg

34102

Pharma Research International, Inc, Naples

35660

Shoals Medical Trials, Inc., Sheffield

37620

PMG Research of Bristol, Bristol

40004

Kentucky Pediatric / Adult Research, Bardstown

40207

Brownsboro Park Pediatrics, Louisville

40356

Michael W. Simon, MD, PSC, Nicholasville

45425

Hometown Urgent Care and Research Center (Dayton), Dayton

50266

The Iowa Clinic, Pc, West Des Moines

55415

Hennepin County Medical Center -Department of Emergency Medicine, Minneapolis

67205

Heartland Research Associates, LLC, Wichita

72401

NEA Baptist Clinic, Jonesboro

75234

Research Across America - Dallas, Dallas

77375

Pediatric Healthcare of Northwest Houston, PA, Tomball

77802

DiscoveResearch, Inc., Byran

80902

Colorado Springs Health Partners /Clinical Research Advantag, Colorado Springs

84075

Wee Care Pediatrics, Syracuse

84095

J. Lewis Research, Inc/Jordan River Family Medicine, Jordan

84109

FirstMed, Salt Lake City

Lewis Research, Inc/Foothill Family Clinic, Salt Lake City

85745

SC Clinical Research, Inc, Tuscon

89104

Clinical Research Center, Las Vegas

90706

So Cal Clinical Research Group, Bellflower

92708

Southland Clinical Research Center, Fountain Valley

93637

Madera Family Medical Group, Madera

Sponsors
All Listed Sponsors
lead

Arbor Pharmaceuticals, Inc.

INDUSTRY

NCT02044341 - Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media | Biotech Hunter | Biotech Hunter