Who is sponsoring NCT00034294?

NCT00034294 is sponsored by Genzyme, a Sanofi Company.

What drugs are being tested in NCT00034294?

Interventions in NCT00034294: GT160-246.

What condition does NCT00034294 study?

NCT00034294 studies Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis, Antibiotic-associated Diarrhea.

Is NCT00034294 still recruiting?

NCT00034294 is currently completed. Last updated 4 March 2015.

Last reviewed 2015-03-04 · How we verify

NCT00034294

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 GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Completed Phase 2 Last updated 4 March 2015

What this trial tests

Phase 2 trial testing GT160-246 in Clostridium Difficile-Associated Diarrhea in 300 participants. Completed in 1 July 2003.

Timeline

1 February 2002

1 July 2003

Quick facts

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	300
Start date	1 February 2002
Estimated completion	1 July 2003
Sites	99 locations across United States, Canada, Puerto Rico, United Kingdom

Drugs / interventions tested

GT160-246 — full drug profile →

Conditions studied

Clostridium Difficile-Associated Diarrhea — all drugs for Clostridium Difficile-Associated Diarrhea →
Clostridium Enterocolitis — all drugs for Clostridium Enterocolitis →
Clostridium Difficile Diarrhea — all drugs for Clostridium Difficile Diarrhea →
Antibiotic-associated Colitis — all drugs for Antibiotic-associated Colitis →

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

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

Sponsor's own description

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. 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. Total length of participation is approximately 10 weeks.

Publications & conference data

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

Novel therapies and preventative strategies for primary and recurrent Clostridium difficile infections.
Dieterle MG, Rao K, Young VB. · · 2019 · cited 44× · PMID 30238983 · DOI 10.1111/nyas.13958
Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives.
Sakari M, Laisi A, Pulliainen AT. · · 2022 · cited 23× · PMID 35099182 · DOI 10.1021/acsinfecdis.1c00296

Verify or expand the search:

Other Genzyme, a Sanofi Company trials

Trials by the same sponsor.

NCT06666413 — China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD · Phase 4 · recruiting
NCT05164055 — Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) · Phase 4 · active not recruiting
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 NCT00034294 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 4 March 2015

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/NCT00034294.

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