NCT04636957

A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)

A Phase III, Multicenter, Randomized, Evaluator-blinded, Parallel-Group, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Externa (AOE)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ⅲ, multicenter, randomized, evaluator-blinded, parallel-group, active-controlled study to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution vs ciprofloxacin 0.3% otic solution in the treatment of AOE, and to assess the pharmacokinetic properties in 12 selected adult subjects. Eligible subjects will be randomized at 1:1 ration to either the treatment arm or control arm. All subject will receive 7 consecutive days of either ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution or ciprofloxacin 0.3% otic solution alone. The main objectives are to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution in the treatment of AOE, and to assess the plasma concentration of ciprofloxacin and fluocinolone acetonide after multiple doses of test drug in 12 adult subjects, and evaluate the PK parameters.

Conditions

• Acute Otitis Externa

Interventions

Type	Name	Description
DRUG	Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution	0.25mL/vial, each vial contains 0.75mg of ciprofloxacin and 0.0625mg of fluocinolone acetonide.
DRUG	Ciprofloxacin 0.3% solution	0.4mL/vial, each vial contains 1.2mg ciprofloxacin

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-12-01
• Completion: 2022-07-01
• First posted: 2020-11-19
• Last updated: 2020-11-19

Locations

1 site across 1 country: China