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| Sponsor: | 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. The total length of participation is approximately 6 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Clostridium Enterocolitis Diarrhea |
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
Hide Study Locations| Australia | |
| Herston, Australia, 4032 | |
| Five Dock, Australia, 2046 | |
| Footscray, Australia, 3011 | |
| Randwick, Australia, 2031 | |
| Perth, Australia, 6000 | |
| South Brisbane, Australia, 4101 | |
| Nedlands, Australia, 6009 | |
| Bedford Park, Australia, 5042 | |
| Cairns, Australia, 4870 | |
| Concord, Australia, 2139 | |
| Kogarah, Australia, 2217 | |
| Parkville, Australia, 3050 | |
| Hobart, Australia, 7000 | |
| Southport, Australia, 4215 | |
| Adelaide, Australia, 5000 | |
| Nambour, Australia, 4560 | |
| Darlinghurst, Australia, 2010 | |
| Woolloongabba, Australia, 4102 | |
| Austria | |
| Oberndorf, Austria, 5110 | |
| Salzburg, Austria, 5020 | |
| Linz, Austria, 4020 | |
| Linz, Austria, 4010 | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| Gent, Belgium, B-9000 | |
| Hasselt, Belgium, 3500 | |
| Yvoir, Belgium, B-5330 | |
| Brussels, Belgium, 1200 | |
| Aalst, Belgium, 9300 | |
| Brussels, Belgium, 1070 | |
| Braine L'Alleud, Belgium, 1420 | |
| Leuven, Belgium, 3000 | |
| Brussels, Belgium, 1000 | |
| Czech Republic | |
| Brno, Czech Republic, 62500 | |
| Hradec Kralove, Czech Republic, 50005 | |
| Praha, Czech Republic, 128 20 | |
| Melnik, Czech Republic, 276 01 | |
| Praha, Czech Republic, 180 81 | |
| Ostrava, Czech Republic, 708 52 | |
| Denmark | |
| Hvidovre, Denmark, DK-2650 | |
| Copenhagen, Denmark, DK-2400 | |
| Copenhagen, Denmark, DK-2200 | |
| Herlev, Denmark, DK-2730 | |
| France | |
| Paris, France, 75018 | |
| Annecy, France, 74000 | |
| Garches, France, 92380 | |
| Nice, France, 06200 | |
| Amiens, France, 80054 | |
| Clichy, France, 92110 | |
| Saint Etienne, France, 42055 | |
| Paris, France, 75010 | |
| Tourcoing, France, 59200 | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Dijon, France, 21000 | |
| Paris, France, 75020 | |
| Paris, France, 75679 | |
| Creteil, France, 94010 | |
| Germany | |
| Köln, Germany, 50937 | |
| Lübeck, Germany, 23538 | |
| Hofheim, Germany, 65719 | |
| Wilhelmshaven, Germany, 26384 | |
| Augsburg, Germany, 86156 | |
| Greifswald, Germany, 17491 | |
| Leipzig, Germany, 4157 | |
| Regensburg, Germany, 93053 | |
| Berlin, Germany, 12200 | |
| Hannover, Germany, 30625 | |
| Düsseldorf, Germany, 40472 | |
| Frankfurt, Germany, 60487 | |
| Frankfurt, Germany, 60590 | |
| Ireland | |
| Cork, Ireland | |
| Dublin, Ireland | |
| Castlebar, Ireland | |
| Dublin, Ireland | |
| Norway | |
| Bergen, Norway, N-5021 | |
| Oslo, Norway, N-0407 | |
| Bergen, Norway, N-5009 | |
| Tromso, Norway, 9038 | |
| Bodo, Norway, N-8005 | |
| Trondheim, Norway, 7006 | |
| Stavanger, Norway, N-4068 | |
| Tonsberg, Norway, 3103 | |
| Portugal | |
| Porto, Portugal, 4099-001 | |
| Matosinhos, Portugal, 4450 | |
| Carnaxide, Portugal, 2790-134 | |
| Coimbra, Portugal, 3000-075 | |
| Spain | |
| Madrid, Spain, 28041 | |
| Alcala de Henares, Spain, 28805 | |
| Lleida, Spain, 25198 | |
| Sevilla, Spain, 41071 | |
| Badalona, Spain, 8915 | |
| Sevilla, Spain, 41013 | |
| San Sebastian, Spain, 20014 | |
| Terrassa, Spain, 8221 | |
| El Palmar-Murcia, Spain, 30120 | |
| Sevilla, Spain, 41014 | |
| Barcelona, Spain, 8025 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08035 | |
| Guadalajara, Spain, 19002 | |
| Santander, Spain, 39008 | |
| Madrid, Spain, 28035 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28040 | |
| Cordoba, Spain, 14004 | |
| Madrid, Spain, 28007 | |
| Leganes, Spain, 28911 | |
| Badalona, Spain, 8911 | |
| Sweden | |
| Kristianstad, Sweden, SE-291 85 | |
| Karlskrona, Sweden, SE-371 85 | |
| Skoevde, Sweden, SE-541 85 | |
| Kalmar, Sweden, SE-391 85 | |
| Lund, Sweden, SE-221 85 | |
| Goteborg, Sweden, SE-416 85 | |
| Oerebro, Sweden, SE-701 85 | |
| Joenkoeping, Sweden, SE-551 85 | |
| Malmö, Sweden, SE-205 85 | |
| Switzerland | |
| Lugano, Switzerland, 6903 | |
| Basel, Switzerland, 4031 | |
| Geneva, Switzerland, 1211 | |
| Baden, Switzerland, 5404 | |
| Bellinzona, Switzerland, 6500 | |
| United Kingdom | |
| London, United Kingdom, SE13 6LH | |
| Sunderland, United Kingdom, SR4 7TP | |
| Keighley, United Kingdom, BD20 6TD | |
| Leeds, United Kingdom, LS1 3EX | |
| Cardiff, United Kingdom, CF64 2XX | |
| Sheffield, United Kingdom, S10 2JF | |
| Bury, United Kingdom, BL9 7TD | |
| Stockport, United Kingdom, SK2 7JE | |
| Liverpool, United Kingdom, L7 8XP | |
| Ipswich, United Kingdom, IP4 5PD | |
| Abergavenny, United Kingdom, NP7 7EG | |
| Birmingham, United Kingdom, B15 2TT | |
| Gwent, United Kingdom, NP20 2UB | |
| Bristol, United Kingdom, BS16 1LE | |
| London, United Kingdom, W1M 3TT | |
| Winchester, United Kingdom, SO22 5DG | |
| Cardiff, United Kingdom, CF14 4XW | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Salford, United Kingdom, M6 8HD | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | GD3-170-302 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00196794 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Pseudomembranous Colitis Clostridium difficile-associated diarrhea C. difficile CDAD |
|
Bacterial Infections Anti-Infective Agents Metronidazole Antiprotozoal Agents Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Physiological Effects of Drugs Enterocolitis, Pseudomembranous Intestinal Diseases Enterocolitis |
Pharmacologic Actions Anti-Bacterial Agents Signs and Symptoms Antiparasitic Agents Gram-Positive Bacterial Infections Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Vancomycin Gastroenteritis Clostridium Infections |
