Drugs / Tolevamer
last change May 2014 re-read 3 minutes ago

Tolevamer

Other / unclassified

Developed for
Clostridium difficile colitis · diarrheal disease · enterocolitis
Investigated by
Genzyme, a Sanofi Company

Trials 5

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT00382304 Sep 2006 → Sep 2007 Clostridium difficile colitis, acute diarrhea Genzyme, a Sanofi Company Completed No outcome recorded
Phase 2 NCT00034294 Feb 2002 → Jul 2003 Clostridium difficile colitis, diarrheal disease, enterocolitis Genzyme, a Sanofi Company Completed No outcome recorded
Phase 33 trials · 2 missed
Phase 3 NCT00466635 Apr → Aug 2007 Clostridium difficile colitis, diarrheal disease Genzyme, a Sanofi Company Terminated No outcome recorded
Phase 3 NCT00196794 Apr 2005 → Aug 2007 Clostridium difficile colitis, diarrheal disease Genzyme, a Sanofi Company Completed Missed primary
Phase 3 NCT00106509 Mar 2005 → Feb 2007 Clostridium difficile colitis Genzyme, a Sanofi Company Completed Missed primary

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as tolevamer ClinicalTrials.gov intervention name — accepted as the source's own label NCT00382304 ↗
3

NCT00106509 ↗

NCT00196794 ↗

NCT00466635 ↗

Known as Exodif “An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea” NCT00466635 ↗
Known as GT160-246 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00034294 ↗
Known as GT267-004 “GT267-004 (tolevamer potassium sodium)” NCT00466635 ↗
2

“tolevamer potassium-sodium (GT267-004)” NCT00382304 ↗

“tolevamer potassium-sodium (GT267-004)” NCT00106509 ↗

Known as tolevamer potassium-sodium “An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea” NCT00466635 ↗
2

“tolevamer potassium-sodium (GT267-004)” NCT00106509 ↗

“tolevamer potassium-sodium (GT267-004)” NCT00382304 ↗

Modality Other / unclassified “tolevamer, a nonantibiotic, toxin-binding polymer” PMID 24799326 ↗ May 2014
Route Oral “oral tolevamer 9 g (loading dose) followed by 3 g every 8 hours for 14 days” PMID 24799326 ↗ May 2014