Trial Details

Not Recruiting
Basic Information
Clinical ID c5102
Identifier EUCTR2014-003002-32-CZ
Trial Title Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE
Trial URL Visit Original Page
Study Information
Study Results

NULL
Conditions Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD) MedDRA version: 18.0.Level: LLT.Classification code 10022661.Term: Intestinal infection due to clostridium difficile.System Or
Interventions Trade Name: DificlirProduct Name: DIFICLIR 200 mg film-coated tabletsPharmaceutical Form: Film-coated tabletINN or Proposed INN: fidaxomicinCAS Number: 873857-62-6Current Sponsor code: OPT-80Other descriptive name: FIDAXOMICIN<
Participant Information
Sponsor Astellas Pharma Europe Ltd.
City NULL
Country/Region France;Czech Republic;Greece;Poland;Austria;Russia;Germany;Italy;United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3|PHASE4
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL