Completed PHASE3 INTERVENTIONAL NCT00106509

A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Sponsor: Genzyme, a Sanofi Company

Conditions Clostridium Enterocolitis Pseudomembranous Colitis

Interventions tolevamer potassium-sodium (GT267-004)

Updated 7 times since 2017 Last updated: Mar 4, 2015 Started: Mar 31, 2005 Completion: Feb 28, 2007

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

This PHASE3 trial investigates Clostridium Enterocolitis and Pseudomembranous Colitis and is currently completed. Genzyme, a Sanofi Company leads this study, which shows 7 recorded versions since 2005 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Dec 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Mar 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genzyme, a Sanofi Company

Data source: Sanofi

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

Study Locations

Ajax, Canada , Akron, United States , Albany, United States , Allentown, United States , Anderson, United States , Asheville, United States , Atlanta, United States , Baltimore, United States , Bay Pines, United States , Boston, United States and 103 more locations