A Phase 3 interventional study of tolevamer potassium-sodium (GT267-004) in Clostridium Enterocolitis and Pseudomembranous Colitis, sponsored by Genzyme, a Sanofi Company. Completed at 140 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Genzyme, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Treatment
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's enrollment of 520 is above 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.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Resolution of diarrhea
Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success
Showing the first 100 of 140 sites across 3 countries. Choose a country and city above to see the rest.
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 →