GD3170302: A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00196794

Purpose

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. Total length of participation is approximately 6 weeks.

Condition	Intervention	Phase
Clostridium Enterocolitis Pseudomembranous Colitis Clostridium Difficile-Associated Diarrhea C. Difficile CDAD	Drug: Tolevamer potassium-sodium (GT267-004)	Phase III

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Further Study Details:

Primary Outcomes: Resolution of diarrhea

Secondary Outcomes: Time to resolution of diarrhea; Recurrence rate; Number of stools; Average stool consistency; Treatment success

Expected Total Enrollment: 520

Study start: April 2005

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

18 years of age

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.

Location and Contact Information

Central Contact:
Medical Information 800-745-4447 MedInfo@genzyme.com
Medical Information 617-252-7832 MedInfo@genzyme.com

Australia

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
St. Leonards, 2065, Australia
Southport, 4215, Australia
Adelaide, 5000, Australia
Nambour, 4560, Australia
Cairns, 4870, Australia
Woolloongabba, 4102, Australia

Austria
Oberndorf, 5110, Austria
Salzburg, 5020, Austria
Linz, 4020, Austria
Linz, 4010, Austria
Innsbruck, 6020, Austria

Belgium
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

Czech Republic
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

Denmark
Hvidovre, DK-2650, Denmark
Herlev, DK-2730, Denmark
Copenhagen, DK-2200, Denmark
Copenhagen, DK-2400, Denmark

France
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

Germany
Köln, 50937, Germany
Lübeck, 23538, Germany
Greifswald, 17491, Germany
Wilhelmshaven, 26384, Germany
Frankfurt, 65929, 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

Ireland
Cork, Ireland
Dublin, Ireland
Dublin, Ireland
Castlebar, Ireland
Dublin, Ireland
Dublin, Ireland

Italy
Cremona, 26100, Italy
Brescia, 25123, Italy
Vicenza, 36100, Italy
Modena, 41100, Italy
Pavia, 27100, Italy
Busto Arsizio, 21052, Italy
Udine, 33100, Italy
Como, 22100, Italy
Milano, 20121, Italy
Bologna, 40138, Italy

Norway
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

Portugal
Porto, 4099-001, Portugal
Coimbra, 3000-075, Portugal
Carnaxide, 2790-134, Portugal
Lisboa, 1150-199, Portugal
Matosinhos, 4450, Portugal

Spain
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
Badalona, 8915, Spain
Leganes, 28911, Spain
Badalona, 8911, Spain

Sweden
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

Switzerland
Lugano, 6903, Switzerland
Bellinzona, 6500, Switzerland
Geneva, 1211, Switzerland
Baden, 5404, Switzerland
Basel, 4031, Switzerland

United Kingdom
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

More Information

Study ID Numbers: GD3170302
ClinicalTrials.gov Identifier: NCT00196794
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency;
Australia: Department of Health and Ageing Therapeutic Goods Administration