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N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

NCT00956748 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-12-03

No results posted yet for this study

Summary

Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.

Conditions

  • Otitis Media
  • Otorrhea

Interventions

DRUG

Ciprodex

Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.

DRUG

Ciprodex and 2% NAC

Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Brian D Westerberg, MD · St. Paul's Hospital Rotary Hearing Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2019-11-29
Completion
2019-11-29

Countries

  • Canada

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 NCT00956748 on ClinicalTrials.gov