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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
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.
Details
| Lead sponsor | Lee's Pharmaceutical Limited |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 360 |
| Start date | 2013-06 |
| Completion | 2014-09 |
Conditions
- Acute Exacerbations of Chronic Bronchitis
Interventions
- Prulifloxacin
- Levofloxacin
- Levofloxacin Placebo
- Prulifloxacin placebo
Primary outcomes
- To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis. — 7-10 days
1. Clinical efficacy: consists of clinical evaluation which expressed as clinical cure and clinical failure. 2. Bacteriological efficacy: consists of eradication, supposed eradication, persistence, supposed persistence, partial eradication,; 3. Comprehensive therapeutic efficacy: consists of cure and failure
Countries
China