A Phase 2 interventional study of tolevamer potassium-sodium (GT267-004) in Pseudomembranous Colitis, Clostridium Difficile Diarrhea and Antibiotic-Associated Diarrhea, sponsored by Genzyme, a Sanofi Company. Completed at 8 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-19.
Sponsored by Genzyme, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment
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.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 29 interventional studies indexed under Enterocolitis, Pseudomembranous.
Browse Enterocolitis, Pseudomembranous studies →Genzyme, a Sanofi Company is the lead sponsor of 308 studies on the registry; 5 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 19 (76%) have results posted.
First submitted before Genzyme became part of Sanofi.
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Exclusion Criteria:
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
The record gives a start of Sep 2006 and a completion of Sep 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tolevamer Potassium Sodium
Enterocolitis, Pseudomembranous →