A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
NCT ID: NCT00196794
Last Updated: 2014-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2005-04-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tolevamer potassium-sodium (GT267-004)
Eligibility Criteria
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Inclusion Criteria
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete 6 week study period.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Adelaide, , Australia
Bedford Park, , Australia
Cairns, , Australia
Concord, , Australia
Darlinghurst, , Australia
Five Dock, , Australia
Footscray, , Australia
Herston, , Australia
Hobart, , Australia
Kogarah, , Australia
Nambour, , Australia
Nedlands, , Australia
Parkville, , Australia
Perth, , Australia
Randwick, , Australia
South Brisbane, , Australia
Southport, , Australia
Woolloongabba, , Australia
Innsbruck, , Austria
Linz, , Austria
Linz, , Austria
Oberndorf, , Austria
Salzburg, , Austria
Aalst, , Belgium
Braine-l'Alleud, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Yvoir, , Belgium
Brno, , Czechia
Hradec Králové, , Czechia
Mělník, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Copenhagen, , Denmark
Copenhagen, , Denmark
Herlev, , Denmark
Hvidovre, , Denmark
Amiens, , France
Annecy, , France
Clichy, , France
Créteil, , France
Dijon, , France
Garches, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Saint-Etienne, , France
Tourcoing, , France
Vandœuvre-lès-Nancy, , France
Augsburg, , Germany
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Greifswald, , Germany
Hanover, , Germany
Hofheim, , Germany
Leipzig, , Germany
Lübeck, , Germany
Regensburg, , Germany
Wilhelmshaven, , Germany
Castlebar, , Ireland
Cork, , Ireland
Dublin, , Ireland
Bergen, , Norway
Bergen, , Norway
Bodø, , Norway
Oslo, , Norway
Stavanger, , Norway
Tromsø, , Norway
Trondheim, , Norway
Tønsberg, , Norway
Carnaxide, , Portugal
Coimbra, , Portugal
Matosinhos Municipality, , Portugal
Porto, , Portugal
Alcalá de Henares, , Spain
Badalona, , Spain
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Donostia / San Sebastian, , Spain
El Palmar-Murcia, , Spain
Guadalajara, , Spain
Leganés, , Spain
Lleida, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Santander, , Spain
Seville, , Spain
Seville, , Spain
Seville, , Spain
Terrassa, , Spain
Gothenburg, , Sweden
Jönköping, , Sweden
Kalmar, , Sweden
Karlskrona, , Sweden
Kristianstad, , Sweden
Lund, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Skövde, , Sweden
Baden, , Switzerland
Basel, , Switzerland
Bellinzona, , Switzerland
Geneva, , Switzerland
Lugano, , Switzerland
Abergavenny, , United Kingdom
Birmingham, , United Kingdom
Bristol, , United Kingdom
Bury, , United Kingdom
Cardiff, , United Kingdom
Cardiff, , United Kingdom
Edinburgh, , United Kingdom
Gwent, , United Kingdom
Ipswich, , United Kingdom
Keighley, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Stockport, , United Kingdom
Sunderland, , United Kingdom
Winchester, , United Kingdom
Countries
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References
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Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.
Other Identifiers
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GD3-170-302
Identifier Type: -
Identifier Source: org_study_id
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