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

> **NCT01994642** · PHASE3 · TERMINATED · sponsor: **Par Pharmaceutical, Inc.** · enrollment: 203 (actual)

## Conditions studied

- 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

## Key facts

- **NCT ID:** NCT01994642
- **Lead sponsor:** Par Pharmaceutical, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2013-11
- **Primary completion:** 2015-03
- **Final completion:** 2015-03
- **Target enrollment:** 203 (ACTUAL)
- **Why stopped:** FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies
- **Last updated:** 2017-09-26

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01994642

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01994642, "Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01994642. Licensed CC0.

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