Trial Details

Not Recruiting
Basic Information
Clinical ID c3028
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

No results available
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 Organ Class: 100000004862_;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Interventions Trade Name: Dificlir Product Name: DIFICLIR 200 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: fidaxomicin CAS Number: 873857-62-6 Current Sponsor code: OPT-80 Other descriptive name: FIDAXOMICIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Participant Information
Sponsor Astellas Pharma Europe Ltd.
City -
Country/Region France;Czech Republic;Greece;Poland;Austria;Russia;Germany;Italy;United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3|PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -