Terminated PHASE4 INTERVENTIONAL 2-arm NCT01775397

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System (FREEDOM)

A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

Sponsor: Astellas Pharma Europe Ltd.

Conditions Clostridium Difficile

Interventions Fidaxomicin Placebo Vancomycin

Updated 8 times since 2017 Last updated: Jan 8, 2020 Started: Nov 29, 2012 Primary completion: Apr 15, 2013 Completion: Apr 15, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study terminated due to difficulty in enrollment

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This PHASE4 trial investigates Clostridium Difficile and is currently terminated or withdrawn. Astellas Pharma Europe Ltd. leads this study, which shows 8 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE4
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE4
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE4
Jan 2024 — Jul 2024 [monthly]

Terminated PHASE4
Jan 2021 — Jan 2024 [monthly]

Terminated PHASE4

▶ Show 3 earlier versions

Feb 2020 — Jan 2021 [monthly]

Terminated PHASE4
Jun 2018 — Feb 2020 [monthly]

Terminated PHASE4
Jan 2017 — Jun 2018 [monthly]

Terminated PHASE4

First recorded

Nov 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Astellas Pharma Europe Ltd.
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Data source: Astellas Pharma Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Athens, Greece , Barcelona, Spain , Berlin, Germany , Brzozów, Poland , Cologne, Germany , Essen, Germany , Halle, Germany , Heraklion, Greece , Herlev, Denmark , Madrid, Spain and 3 more locations