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

NCT04636957 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-11-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-12-31
Completion
2022-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636957 on ClinicalTrials.gov