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Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.

NCT03729258 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-05

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy and safety of cefpodoxime 200 mg immediate (b.i.d) and cefpodoxime 400 mg modified release (q.d) tablet formulations in the treatment of acute bacterial rhinosinusitis.

Conditions

  • Sinusitis
  • Sinusitis, Acute
  • Rhinosinusitis
  • Rhinosinusitis Acute
  • Sinus Infection

Interventions

DRUG

Infex 400 MR

Infex (cefpodoxime) 400mg once a day (QD) for 10 days

DRUG

Infex 200 IR

Infex (cefpodoxime) 200mg twice a day (BID) for 10 days

Sponsors & Collaborators

  • Neutec Ar-Ge San ve Tic A.Ş

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2023-10-01
Completion
2023-12-01

Countries

  • Turkey (Türkiye)

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 NCT03729258 on ClinicalTrials.gov