# A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa

> **NCT01910155** · PHASE3 · TERMINATED · sponsor: **Par Pharmaceutical, Inc.** · enrollment: 455 (actual)

## Conditions studied

- Otitis Externa

## Interventions

- **DRUG:** Ciprofloxacin/Dexamethasone
- **DRUG:** Ciprodex (R)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01910155
- **Lead sponsor:** Par Pharmaceutical, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2013-07
- **Primary completion:** 2015-02
- **Final completion:** 2015-03
- **Target enrollment:** 455 (ACTUAL)
- **Why stopped:** FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.
- **Last updated:** 2016-10-18

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01910155

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01910155, "A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01910155. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*