A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
Public ClinicalTrials.gov record NCT01910155. 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, Placebo-Controlled, 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 Adults With Acute Bacterial Otitis Externa
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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
Study identification
- NCT ID
- NCT01910155
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 455 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Jul 2013 (Type not available)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Oct 18, 2016
2013 – 2015
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| James Donivan Gordon, MD | Tucson | Arizona | 85745 | — |
| Nea Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| Applied Reserch Center | Little Rock | Arkansas | 72212 | — |
| John Champlin, MD | Carmichael | California | 95608 | — |
| Aliance Research | Long Beach | California | 90813 | — |
| ENT of South Florida | Boyton Beach | Florida | 33426 | — |
| Moore Clinical Research Inc | Fort Myers | Florida | 33919 | — |
| Jorge Diaz, MD | Hialeah | Florida | 33016 | — |
| San Marcus Research Clinic | Miami | Florida | 33015 | — |
| The Medical Consulting Center | Miami | Florida | 33125 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Winter Park Clinical Research | Winter Park | Florida | 32792 | — |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | — |
| Pioneer Clinical Research | Bellevue | Nebraska | 68005 | — |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | — |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | — |
| Julia Mullen, MD | Cincinnati | Ohio | 45246 | — |
| Integrated Medical Research PC | Ashland | Oregon | 97520 | — |
| Cyn3rgy | Gresham | Oregon | 97030 | — |
| Peak Research LLC | Upper Saint Clair | Pennsylvania | 15241 | — |
| John Ansley, MD | Orangeburg | South Carolina | 29118 | — |
| Spartanburg and Geer ENT | Spartanburg | South Carolina | 29303 | — |
| Monica Davis, MD | Brentwood | Tennessee | 37027 | — |
| Gilbert Ledesma, MD | Arlington | Texas | 76012 | — |
| West Houston Clinical Research Service | Houston | Texas | 77055 | — |
| R-D Clinical Research | Lake Jackson | Texas | 77566 | — |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01910155, 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 Oct 18, 2016 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01910155 live on ClinicalTrials.gov.