Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
Public ClinicalTrials.gov record NCT01994642. 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 Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.
Study identification
- NCT ID
- NCT01994642
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 203 participants
Conditions and interventions
Interventions
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension Drug
- CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) Drug
- Placebo Sterile Otic Suspension Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Months to 12 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
- Nov 2013 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Sep 26, 2017
2013 – 2015
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pediatrics | Birmingham | Alabama | 32505 | — |
| Agave Clinical Ressearch | Mesa | Arizona | 85202 | — |
| Arizona Center for Clinical Trials | Phoenix | Arizona | 85003 | — |
| Visions Clinical Research, Tuscon | Tucson | Arizona | 85712 | — |
| Alliance Research | Long Beach | California | 90813 | — |
| San Marcus Research Clinic | Miami | Florida | 33015 | — |
| Florida Medical Center and Research Inc. | Miami | Florida | 33142 | — |
| South Miami Clinical Research Group | Miami | Florida | 33142 | — |
| Miami Dade Medical Resarch Institute | Miami | Florida | 33176 | — |
| Global Health Research Center | Miami Lakes | Florida | 33016 | — |
| Winter Park Clinical Research | Winter Park | Florida | 32792 | — |
| Research Integrity | Owensboro | Kentucky | 42303 | — |
| Dr. Craig Spiegel | Bridgeton | Missouri | 63044 | — |
| Dr. Scott Mathei | Henderson | Nevada | 89704 | — |
| Piedmont Ear Nose and Throat Associates, PA | Winston-Salem | North Carolina | 27103 | — |
| Accecss MD, Clinical Resarch | Huber Heights | Ohio | 45424 | — |
| Cyn3gry | Gresham | Oregon | 97030 | — |
| Rainbow Research, Inc | Barnwell | South Carolina | 29812 | — |
| Dr. John Ansley | Orangeburg | South Carolina | 29118 | — |
| Spartanburg and Greer ENT | Spartanburg | South Carolina | 29303 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| Eagle Family Medical Associates | Crossville | Tennessee | 38555 | — |
| The Education and Research Foundation, Inc | Lynchburg | Virginia | 24501 | — |
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 NCT01994642, 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 Sep 26, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01994642 live on ClinicalTrials.gov.