A Phase 3 interventional study of Tolevamer potassium-sodium (GT267-004) in Clostridium Enterocolitis and Diarrhea, sponsored by Genzyme, a Sanofi Company. Completed at 138 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.
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 Australia and Europe. 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. The 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 138 sites across 14 countries. Choose a country and city above to see the rest.
The record gives a start of Apr 2005 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2014. 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 →