Who is sponsoring NCT00382304?

NCT00382304 is sponsored by Genzyme, a Sanofi Company.

What drugs are being tested in NCT00382304?

Interventions in NCT00382304: tolevamer potassium-sodium (GT267-004).

What condition does NCT00382304 study?

NCT00382304 studies Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea.

Is NCT00382304 still recruiting?

NCT00382304 is currently completed. Last updated 17 March 2015.

Last reviewed 2015-03-17 · How we verify

NCT00382304

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

A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Completed Phase 2 Last updated 17 March 2015

What this trial tests

Phase 2 trial testing tolevamer potassium-sodium (GT267-004) in Pseudomembranous Colitis in 24 participants. Completed in 1 September 2007.

Timeline

1 September 2006

1 September 2007

Quick facts

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 September 2006
Estimated completion	1 September 2007
Sites	8 locations across Canada

Drugs / interventions tested

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

Conditions studied

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

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with Pseudomembranous Colitis or Clostridium Difficile 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.

The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis

Sponsor's own description

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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
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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 NCT00382304 (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: 17 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/NCT00382304.

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