A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Enterocolitis; Diarrhea
Intervention: Tolevamer potassium-sodium (GT267-004) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
David Davidson, M.D., Study Director, Affiliation: Genzyme
Gerard Short, MB, BS, Study Director, Affiliation: Genzyme Corporation, Europe
Summary
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.
Clinical Details
Official title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Resolution of diarrhea
Secondary outcome: Time to resolution of diarrheaRecurrence rate Number of stools Average stool consistency Treatment success
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years of age and above
- 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.
Locations and Contacts
Herston 4032, Australia
Five Dock 2046, Australia
Footscray 3011, Australia
Randwick 2031, Australia
Perth 6000, Australia
South Brisbane 4101, Australia
Nedlands 6009, Australia
Bedford Park 5042, Australia
Darlinghurst 2010, Australia
Concord 2139, Australia
Kogarah 2217, Australia
Parkville 3050, Australia
Hobart 7000, Australia
Southport 4215, Australia
Adelaide 5000, Australia
Nambour 4560, Australia
Cairns 4870, Australia
Woolloongabba 4102, Australia
Oberndorf 5110, Austria
Salzburg 5020, Austria
Linz 4020, Austria
Linz 4010, Austria
Innsbruck 6020, Austria
Gent B-9000, Belgium
Hasselt 3500, Belgium
Yvoir B-5330, Belgium
Brussels 1200, Belgium
Aalst 9300, Belgium
Brussels 1070, Belgium
Braine L'Alleud 1420, Belgium
Leuven 3000, Belgium
Brussels 1000, Belgium
Brno 62500, Czech Republic
Hradec Kralove 50005, Czech Republic
Praha 128 20, Czech Republic
Melnik 276 01, Czech Republic
Praha 180 81, Czech Republic
Ostrava 708 52, Czech Republic
Hvidovre DK-2650, Denmark
Herlev DK-2730, Denmark
Copenhagen DK-2200, Denmark
Copenhagen DK-2400, Denmark
Paris 75018, France
Annecy 74000, France
Dijon 21000, France
Nice 06200, France
Amiens 80054, France
Clichy 92110, France
Saint Etienne 42055, France
Paris 75010, France
Tourcoing 59200, France
Vandoeuvre-les-Nancy 54511, France
Garches 92380, France
Paris 75020, France
Paris 75679, France
Creteil 94010, France
Köln 50937, Germany
Lübeck 23538, Germany
Greifswald 17491, Germany
Wilhelmshaven 26384, Germany
Augsburg 86156, Germany
Hofheim 65719, Germany
Leipzig 4157, Germany
Regensburg 93053, Germany
Berlin 12200, Germany
Hannover 30625, Germany
Düsseldorf 40472, Germany
Frankfurt 60487, Germany
Frankfurt 60590, Germany
Cork, Ireland
Dublin, Ireland
Castlebar, Ireland
Dublin, Ireland
Bergen N-5021, Norway
Bodo N-8005, Norway
Bergen N-5009, Norway
Tromso 9038, Norway
Oslo N-0407, Norway
Trondheim 7006, Norway
Stavanger N-4068, Norway
Tonsberg 3103, Norway
Porto 4099-001, Portugal
Coimbra 3000-075, Portugal
Carnaxide 2790-134, Portugal
Matosinhos 4450, Portugal
Madrid 28041, Spain
Alcala de Henares 28805, Spain
Lleida 25198, Spain
Madrid 28007, Spain
Badalona 8915, Spain
Sevilla 41013, Spain
San Sebastian 20014, Spain
Terrassa 8221, Spain
El Palmar-Murcia 30120, Spain
Sevilla 41014, Spain
Barcelona 8025, Spain
Barcelona 08036, Spain
Barcelona 08035, Spain
Guadalajara 19002, Spain
Santander 39008, Spain
Madrid 28035, Spain
Madrid 28040, Spain
Madrid 28040, Spain
Cordoba 14004, Spain
Sevilla 41071, Spain
Leganes 28911, Spain
Badalona 8911, Spain
Kristianstad SE-291 85, Sweden
Karlskrona SE-371 85, Sweden
Goteborg SE-416 85, Sweden
Kalmar SE-391 85, Sweden
Lund SE-221 85, Sweden
Skoevde SE-541 85, Sweden
Oerebro SE-701 85, Sweden
Joenkoeping SE-551 85, Sweden
Malmö SE-205 85, Sweden
Lugano 6903, Switzerland
Bellinzona 6500, Switzerland
Geneva 1211, Switzerland
Baden 5404, Switzerland
Basel 4031, Switzerland
London SE13 6LH, United Kingdom
Sunderland SR4 7TP, United Kingdom
Salford M6 8HD, United Kingdom
Leeds LS1 3EX, United Kingdom
Cardiff CF64 2XX, United Kingdom
Sheffield S10 2JF, United Kingdom
Bury BL9 7TD, United Kingdom
Stockport SK2 7JE, United Kingdom
Liverpool L7 8XP, United Kingdom
Ipswich IP4 5PD, United Kingdom
Abergavenny NP7 7EG, United Kingdom
Birmingham B15 2TT, United Kingdom
Gwent NP20 2UB, United Kingdom
Bristol BS16 1LE, United Kingdom
London W1M 3TT, United Kingdom
Winchester SO22 5DG, United Kingdom
Cardiff CF14 4XW, United Kingdom
Edinburgh EH4 2XU, United Kingdom
Keighley BD20 6TD, United Kingdom
Additional Information
Starting date: April 2005
Ending date: August 2007
Last updated: August 17, 2007
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