Who is sponsoring NCT00196794?

NCT00196794 is sponsored by Genzyme, a Sanofi Company.

What drugs are being tested in NCT00196794?

Interventions in NCT00196794: Tolevamer potassium-sodium (GT267-004).

What condition does NCT00196794 study?

NCT00196794 studies Clostridium Enterocolitis, Diarrhea.

Is NCT00196794 still recruiting?

NCT00196794 is currently completed. Last updated 17 March 2014.

Last reviewed 2014-03-17 · How we verify

NCT00196794

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 17 March 2014

What this trial tests

Phase 3 trial testing Tolevamer potassium-sodium (GT267-004) in Clostridium Enterocolitis in 520 participants. Completed in 1 August 2007.

Timeline

1 April 2005

1 August 2007

Quick facts

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	520
Start date	1 April 2005
Estimated completion	1 August 2007
Sites	138 locations across Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland

Drugs / interventions tested

Tolevamer potassium-sodium (GT267-004) — full drug profile →

Conditions studied

Clostridium Enterocolitis — all drugs for Clostridium Enterocolitis →
Diarrhea — all drugs for Diarrhea →

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with Clostridium Enterocolitis or Diarrhea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Resolution of diarrhea

Sponsor's own description

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials.
Johnson S, Louie TJ, Gerding DN, Cornely OA, et al · · 2014 · cited 375× · PMID 24799326 · DOI 10.1093/cid/ciu313
Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives.
Sakari M, Laisi A, Pulliainen AT. · · 2022 · cited 23× · PMID 35099182 · DOI 10.1021/acsinfecdis.1c00296
Fecal Microbiota Transplantation May Be the Best Option in Treating Multiple Clostridioides difficile Infection: A Network Meta-Analysis.
Dembrovszky F, Gede N, Szakács Z, Hegyi P, et al · · 2021 · cited 11× · PMID 33106983 · DOI 10.1007/s40121-020-00356-9

Verify or expand the search:

Other Genzyme, a Sanofi Company trials

Trials by the same sponsor.

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NCT05134571 — China Post-marketing Surveillance (PMS) Study of Aldurazyme® · Phase 4 · completed
NCT05054387 — China Post-marketing Surveillance (PMS) Study of Fabrazyme® · Phase 4 · completed
NCT04676373 — Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00196794 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genzyme, a Sanofi Company
Last refreshed: 17 March 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00196794.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing