A Phase 3 interventional study of GT267-004 (tolevamer potassium sodium) in Enterocolitis, Pseudomembranous, Diarrhea and Clostridium Difficile, sponsored by Genzyme, a Sanofi Company. Terminated at 13 sites in United States. 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 3, Interventional, and Treatment
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's planned enrollment of 65 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical Success
Safety
The extent of tolevamer absorption
The record gives a start of Apr 2007 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 terminated, 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 →