Trials / Completed
CompletedNCT01208922
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 835 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rifamycin SV-MMX® | 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. |
| DRUG | Ciprofloxacin | 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d. |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2016-01-01
- Completion
- 2016-05-01
- First posted
- 2010-09-24
- Last updated
- 2019-02-27
- Results posted
- 2019-02-27
Locations
19 sites across 3 countries: Ecuador, Guatemala, India
Source: ClinicalTrials.gov record NCT01208922. Inclusion in this directory is not an endorsement.