Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolevamer potassium-sodium (GT267-004) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of diarrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of diarrhea | ||
| Recurrence rate | ||
| Number of stools |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | 5000 | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24799326 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Average stool consistency |
| Treatment success |
| Bedford Park |
| 5042 |
| Australia |
| Cairns | 4870 | Australia |
| Concord | 2139 | Australia |
| Darlinghurst | 2010 | Australia |
| Five Dock | 2046 | Australia |
| Footscray | 3011 | Australia |
| Herston | 4032 | Australia |
| Hobart | 7000 | Australia |
| Kogarah | 2217 | Australia |
| Nambour | 4560 | Australia |
| Nedlands | 6009 | Australia |
| Parkville | 3050 | Australia |
| Perth | 6000 | Australia |
| Randwick | 2031 | Australia |
| South Brisbane | 4101 | Australia |
| Southport | 4215 | Australia |
| Woolloongabba | 4102 | Australia |
| Innsbruck | 6020 | Austria |
| Linz | 4010 | Austria |
| Linz | 4020 | Austria |
| Oberndorf | 5110 | Austria |
| Salzburg | 5020 | Austria |
| Aalst | 9300 | Belgium |
| Braine-l'Alleud | 1420 | Belgium |
| Brussels | 1000 | Belgium |
| Brussels | 1070 | Belgium |
| Brussels | 1200 | Belgium |
| Ghent | B-9000 | Belgium |
| Hasselt | 3500 | Belgium |
| Leuven | 3000 | Belgium |
| Yvoir | B-5330 | Belgium |
| Brno | 62500 | Czechia |
| Hradec Králové | 50005 | Czechia |
| Mělník | 276 01 | Czechia |
| Ostrava | 708 52 | Czechia |
| Prague | 128 20 | Czechia |
| Prague | 180 81 | Czechia |
| Copenhagen | DK-2200 | Denmark |
| Copenhagen | DK-2400 | Denmark |
| Herlev | DK-2730 | Denmark |
| Hvidovre | DK-2650 | Denmark |
| Amiens | 80054 | France |
| Annecy | 74000 | France |
| Clichy | 92110 | France |
| Créteil | 94010 | France |
| Dijon | 21000 | France |
| Garches | 92380 | France |
| Nice | 06200 | France |
| Paris | 75010 | France |
| Paris | 75018 | France |
| Paris | 75020 | France |
| Paris | 75679 | France |
| Saint-Etienne | 42055 | France |
| Tourcoing | 59200 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Augsburg | 86156 | Germany |
| Berlin | 12200 | Germany |
| Cologne | 50937 | Germany |
| Düsseldorf | 40472 | Germany |
| Frankfurt | 60487 | Germany |
| Frankfurt | 60590 | Germany |
| Greifswald | 17491 | Germany |
| Hanover | 30625 | Germany |
| Hofheim | 65719 | Germany |
| Leipzig | 4157 | Germany |
| Lübeck | 23538 | Germany |
| Regensburg | 93053 | Germany |
| Wilhelmshaven | 26384 | Germany |
| Castlebar | Ireland |
| Cork | Ireland |
| Dublin | Ireland |
| Bergen | N-5009 | Norway |
| Bergen | N-5021 | Norway |
| Bodø | N-8005 | Norway |
| Oslo | N-0407 | Norway |
| Stavanger | N-4068 | Norway |
| Tromsø | 9038 | Norway |
| Trondheim | 7006 | Norway |
| Tønsberg | 3103 | Norway |
| Carnaxide | 2790-134 | Portugal |
| Coimbra | 3000-075 | Portugal |
| Matosinhos Municipality | 4450 | Portugal |
| Porto | 4099-001 | Portugal |
| Alcalá de Henares | 28805 | Spain |
| Badalona | 8911 | Spain |
| Badalona | 8915 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 8025 | Spain |
| Córdoba | 14004 | Spain |
| Donostia / San Sebastian | 20014 | Spain |
| El Palmar-Murcia | 30120 | Spain |
| Guadalajara | 19002 | Spain |
| Leganés | 28911 | Spain |
| Lleida | 25198 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28035 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28041 | Spain |
| Santander | 39008 | Spain |
| Seville | 41013 | Spain |
| Seville | 41014 | Spain |
| Seville | 41071 | Spain |
| Terrassa | 8221 | Spain |
| Gothenburg | SE-416 85 | Sweden |
| Jönköping | SE-551 85 | Sweden |
| Kalmar | SE-391 85 | Sweden |
| Karlskrona | SE-371 85 | Sweden |
| Kristianstad | SE-291 85 | Sweden |
| Lund | SE-221 85 | Sweden |
| Malmö | SE-205 85 | Sweden |
| Örebro | SE-701 85 | Sweden |
| Skövde | SE-541 85 | Sweden |
| Baden | 5404 | Switzerland |
| Basel | 4031 | Switzerland |
| Bellinzona | 6500 | Switzerland |
| Geneva | 1211 | Switzerland |
| Lugano | 6903 | Switzerland |
| Abergavenny | NP7 7EG | United Kingdom |
| Birmingham | B15 2TT | United Kingdom |
| Bristol | BS16 1LE | United Kingdom |
| Bury | BL9 7TD | United Kingdom |
| Cardiff | CF14 4XW | United Kingdom |
| Cardiff | CF64 2XX | United Kingdom |
| Edinburgh | EH4 2XU | United Kingdom |
| Gwent | NP20 2UB | United Kingdom |
| Ipswich | IP4 5PD | United Kingdom |
| Keighley | BD20 6TD | United Kingdom |
| Leeds | LS1 3EX | United Kingdom |
| Liverpool | L7 8XP | United Kingdom |
| London | SE13 6LH | United Kingdom |
| London | W1M 3TT | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| Stockport | SK2 7JE | United Kingdom |
| Sunderland | SR4 7TP | United Kingdom |
| Winchester | SO22 5DG | United Kingdom |
| ID | Term |
|---|---|
| D004761 | Enterocolitis, Pseudomembranous |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided