Text Size

ACT-179811 in Patients With Clostridium Difficile Infection (CDI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01222702
First received: October 8, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

Subjects with Clostridium Difficile Infection (CDI) are randomized and then treated with study drug for 10 days.

At the end of treatment, cure is assessed; subjects are then followed-up to assess any disease recurrence.


Condition Intervention Phase
Clostridium Difficile Infection
 Drug: ACT-179811
Drug: Comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety & Tolerability of 3 Doses of ACT-179811 in Subjects With Clostridium Difficile Infection

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Clinical cure rate after treatment of ACT-179811. [ Time Frame: Up to 10 days treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease recurrence rate following treatment with ACT-179811. [ Time Frame: In average 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational drug - Dose 1 Drug: ACT-179811
ACT-179811 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily.
Experimental: Investigational drug - Dose 2 Drug: ACT-179811
ACT-179811 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily.
Experimental: Investigational drug - Dose 3 Drug: ACT-179811
ACT-179811 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily.
Active Comparator: Matching comparator Drug: Comparator
Active comparator or matching placebo administered orally four times daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female
  • at least 18 year old
  • CDI 1st occurrence or 1st recurrence

Exclusion Criteria:

  • concurrent life threatening condition
  • concomitant antimicrobial treatment for CDI
  • concomitant treatment with another investigational drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222702

  Show 23 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Pascal Charef, DVM Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01222702     History of Changes
Other Study ID Numbers: AC-061A201
Study First Received: October 8, 2010
Last Updated: November 29, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
CDIFF
CDI
CDAD
Clostridium difficile infection

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013