A multi-center, double-blind, randomized, active reference, parallel group study to evaluate the efficacy, safety and tolerability of a 10-day twice daily oral administration of 3 doses of ACT-179811 in subjects with Clostridium difficile infection (CDI). - ND

• Conditions: Clostridium Difficile Infection; MedDRA version: 9.1Level: LLTClassification code 10054236

• Registration Number: EUCTR2010-020941-29-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1.Male or female = 18 years of age at the screening visit
2.Subject with a diagnosis of CDI*.
•First occurrence: no other episode of CDI in the three months prior to the screening visit,
or
•First recurrence: maximum one other episode of CDI in the three months prior to the screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Antimicrobial treatment for current episode of CDI
2.Treatment with another investigational drug
3.Immuno-compromised, immuno-suppressive treatment
4.Concurrent life-threatening condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified