CompletedPhase 2

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

Canada24 participantsStarted 2006-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea Exclusion Criteria: * \> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD * Patient not considered sufficiently stable clinically to complete the study period

What they're measuring

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

Trial details

NCT IDNCT00382304

SponsorGenzyme, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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