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A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control

NCT02157571 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-06-06

No results posted yet for this study

Summary

The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.

Conditions

  • Acute Exacerbations of Chronic Bronchitis

Interventions

DRUG

Prulifloxacin

600 mg/tablet, oral administration of a single tablet.

DRUG

Levofloxacin

500 mg/tablet, oral administration of a tablet daily.

DRUG

Levofloxacin Placebo

Placebo of levofloxacin hydrochloride tablet, without active components.

DRUG

Prulifloxacin placebo

Placebo of prulifloxacin film-coated tablet without active components.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • China

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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 NCT02157571 on ClinicalTrials.gov