Trial record 1 of 1 for:    NCT 01983683
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Phase 3 Study With Cadazolid in CDAD (AC061A302)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01983683
First received: November 7, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

Subjects with CDAD 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 Associated Diarrhea
Drug: Cadazolid
Drug: vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: AC-061A302, A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD).

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Clinical Cure at End of Treatment [ Time Frame: End of Treatment(10 days after starting study drug) +2days ] [ Designated as safety issue: No ]
    Resolution of Diarrhea AND No additional CDAD treatment.


Secondary Outcome Measures:
  • Sustained Cure [ Time Frame: End of Treatment(10 days after starting study drug) +28-32 days ] [ Designated as safety issue: No ]
    Clinical Cure AND No Recurrence.

  • Time to Resolution of Diarrhea [ Time Frame: Baseline to End of Treatment(10 days after starting study drug) ] [ Designated as safety issue: No ]
    The time between the first dose of study drug and Resolution of Diarrhea.

  • CDAD Symptoms [ Time Frame: Baseline to End of Treamtent(10 days after starting study drug) +2 days ] [ Designated as safety issue: No ]
    Change from baseline to End of Treatment +2days in CDAD Symptoms as measured by the DaySyms Patient Reported Outcome (PRO).


Estimated Enrollment: 640
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vancomycin
Vancomycin 125 mg qid or matching placebo capsules
Drug: vancomycin
Oral vancomycin 125 mg or matching placebo capsules 4 times daily
Other Name: vancomycin
Experimental: Cadazolid
Cadazolid 250 mg bid or matching placebo granules
Drug: Cadazolid
Cadazolid 250 mg or matching placebo oral suspension twice daily.
Other Name: ACT-179811

Detailed Description:

An interventional study to investigate the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

  Eligibility

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

Inclusion Criteria:

  • Signed Informed Consent.
  • Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
  • Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.

Exclusion Criteria:

  • More than one previous episode of CDAD in the 3-month period prior to randomization.
  • Evidence of life-threatening or fulminant CDAD.
  • Likelihood of death within 72 hours from any cause.
  • History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
  • Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
  • Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
  • Unable or unwilling to comply with all protocol requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983683

Contacts
Contact: Global Medical Information medinfo@actelion.com

  Show 80 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Paul McGovern, MD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01983683     History of Changes
Other Study ID Numbers: AC-061A302
Study First Received: November 7, 2013
Last Updated: September 30, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Slovakia: State Institute for Drug Control
Korea: Ministry of Food and Drug Safety
United States: Food and Drug Administration

Keywords provided by Actelion:
Clostridium difficile infection
Post-antibiotic diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014