Study Details

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Study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02437591

Astellas Study ID

The unique identification code given by the study sponsor.

2819-MA-1003

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2014-003002-32

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Condition

Inflammatory Bowel Disease (IBD), Infections

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Aug 2015 - Oct 2016

Masking

None (Open Label)

Enrollment number

25

Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for Study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site CZ42002

Ostrava - Vitkovice, Czech Republic, 703 84

Site PL48001

Zgierz, Poland, 95-100

Site GR30002

Athens, Greece, 10675

Site CZ42001

Prague 7, Czech Republic, 170 00

Site PL48004

Lodz, Poland, 91-347

Site GR30004

Athens, Greece, 11527

Site PL48003

Warsaw, Poland, 02-781

Site GB44001

Bournemouth, United Kingdom, BH7 7DW

Site IT39001

Roma, Italy

Site PL48002

Warszawa, Poland, 02-507

Site FR33002

CLICHY, France, 92110

Site GB44002

London, United Kingdom, E11 1NR

Site GB44005

Blackpool, United Kingdom, FY3 8NR

Site DE49002

Hamburg, Germany, 25599

Site RU70001

Saint Petersburg, Russian Federation, 196247

Site GB44003

Nottingham, United Kingdom, NG7 2UH

Site RU70002

Moscow, Russian Federation, 129110

Site GR30003

Thessaloniki, Greece, 546 42

Site IT39003

Padova, Italy, 35128

Site RU70003

Moscow, Russian Federation, 119435

Site FR33001

PARIS, France, 75012

Site AT43002

Vienna, Austria, 1090

Site AT43003

Vienna, Austria, 1030

Site AT43004

Linz, Austria, 4020

Site DE49001

Jena, Germany, 07747

Site GR30001

Athens, Greece, 115 27

Site IT39002

Milano, Italy, 20157

Site AT43001

Graz, Austria, 8036

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