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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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020941-29-SE
Enrollment
92
Registered
2010-10-07
Start date
2010-11-03
Completion date
Unknown
Last updated
2013-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium difficile infection MedDRA version: 12.1 Level: LLT Classification code 10054236 Term: Clostridium difficile infection

Interventions

Product Name: ACT-179811 Product Code: ACT-179811 Pharmaceutical Form: Powder for oral suspension CAS Number: 1025097-10-2 Current Sponsor code: ACT-179811 Concentration unit: mg milligram(s) Concentr

Sponsors

Actelion Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male or female. At least 18 years old. Subject with a diagnosis of CDI: first occurrence or first recurrence. 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

Exclusion criteria: Concurrent life threatening condition. Immuno-compromised subjects, concomittant immuno-suppresive treatment. Concomitant antimicrobial treatment for CDI. Concomitant treatment with another investigational drug.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of a 10-day twice daily (b.i.d.) oral administration of 3 doses of ACT-179811 on cure.;Secondary Objective: To evaluate the effect of ACT-179811 on disease recurrence and its safety and tolerability in subjects with CDI;Primary end point(s): Cure.—

Countries

Germany, Italy, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 15, 2026