Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

PHASE3TerminatedINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Otitis Media in Patients With Tympanostomy Tubes
Interventions
DRUG

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

DRUG

CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

DRUG

Placebo Sterile Otic Suspension

Trial Locations (23)

24501

The Education and Research Foundation, Inc, Lynchburg

27103

Piedmont Ear Nose and Throat Associates, PA, Winston-Salem

29118

Dr. John Ansley, Orangeburg

29303

Spartanburg and Greer ENT, Spartanburg

29812

Rainbow Research, Inc, Barnwell

32505

Birmingham Pediatrics, Birmingham

32792

Winter Park Clinical Research, Winter Park

33015

San Marcus Research Clinic, Miami

33016

Global Health Research Center, Miami Lakes

33142

Florida Medical Center and Research Inc., Miami

South Miami Clinical Research Group, Miami

33176

Miami Dade Medical Resarch Institute, Miami

37620

PMG Research of Bristol, Bristol

38555

Eagle Family Medical Associates, Crossville

42303

Research Integrity, Owensboro

45424

Accecss MD, Clinical Resarch, Huber Heights

63044

Dr. Craig Spiegel, Bridgeton

85003

Arizona Center for Clinical Trials, Phoenix

85202

Agave Clinical Ressearch, Mesa

85712

Visions Clinical Research, Tuscon, Tucson

89704

Dr. Scott Mathei, Henderson

90813

Alliance Research, Long Beach

97030

Cyn3gry, Gresham

All Listed Sponsors
collaborator

Novum Pharmaceutical Research Services

INDUSTRY

lead

Par Pharmaceutical, Inc.

INDUSTRY