Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. 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 10 weeks.

Condition	Treatment or Intervention	Phase
Clostridium difficile-Associated Diarrhea Clostridium Enterocolitis Clostridium Difficile Diarrhea Antibiotic-Associated Colitis Antibiotic-Associated Diarrhea	Drug: GT160-246	Phase II

Further Study Details: 

Expected Total Enrollment:  300

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

Criteria

• Be at least 18 years old.
• Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
• Be able to tolerate oral medication.
• Not be pregnant or breast-feeding.
• Sign and date an informed consent form.

Alabama
      University of Southern Alabama, Mobile,  Alabama,  36617,  United States
Arizona
      University of Arizona, Department of Surgery, Tucson,  Arizona,  85724,  United States
      PACT, Phoenix,  Arizona,  85006,  United States
Arkansas
      Physician's Group Research Clinic, Little Rock,  Arkansas,  72205,  United States
California
      University of California, Davis, Sacramento,  California,  95816,  United States
Delaware
      Christiana Care Health Services, Newark,  Delaware,  19718,  United States
Florida
      Anchor Research Center, Naples,  Florida,  34102,  United States
      Florida I.D. Group, Orlando,  Florida,  32806,  United States
      Bay Pines VAMC, Bay Pines,  Florida,  33744,  United States
      PAB Clinical Research, Brandon,  Florida,  33511,  United States
      Horizon Institute for Clinical Research, Hollywood,  Florida,  33021,  United States
Georgia
      The Medical Center, Department of Clinical Research, Columbus,  Georgia,  31902,  United States
      Protocare Trials, Austell,  Georgia,  30106,  United States
Illinois
      Northwestern Center for Clinical Research, Chicago,  Illinois,  60611,  United States
      North Chicago VA Medical Center, North Chicago,  Illinois,  60064,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
Indiana
      Southeastern Indiana Gastroenterology, Columbus,  Indiana,  47203,  United States
Iowa
      Clinical Trials Office, Des Moines,  Iowa,  50309,  United States
      Chest Infectious Disease and Critical Care Associates PC, Des Moines,  Iowa,  50314,  United States
Kansas
      Wesley Medical Center, Wichita,  Kansas,  67214,  United States
Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536-0084,  United States
      University of Louisville, Louisville,  Kentucky,  40202,  United States
Louisiana
      LSU HealthSciences Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  21215,  United States
      Metropolitan Gastroenterology Group Chevy Chase Clinical Research, Chevy Chase,  Maryland,  20815,  United States
Massachusetts
      New England Medical Center, Boston,  Massachusetts,  02111,  United States
      VA Boston HCS, West Roxbury,  Massachusetts,  02132,  United States
      Health South Clinical Research, Braintree,  Massachusetts,  02185,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
      Bio-Test Clinic, Springfield,  Missouri,  65807,  United States
New Jersey
      UMONJ-SOM, Stratford,  New Jersey,  08084,  United States
New York
      Erie County Medical Center, JP, Buffalo,  New York,  14215,  United States
      Center for Liver Disease and Transplantation, PA14 Columbia Presbyterian Med. Center, New York,  New York,  10032,  United States
      VA Medical Center, Syracuse,  New York,  13210,  United States
      VA NY Harbor Health Care System, Div of Gastroenterology, New York,  New York,  10010,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      St. Vincent Catholic Medical Center, Jamaica,  New York,  11432,  United States
North Carolina
      Carolinas Medical Center Department of Internal Medicine, Charlotte,  North Carolina,  28203,  United States
      Asheville Gastroenterology Associates, Asheville,  North Carolina,  28801,  United States
North Dakota
      Meritcare Hospital Pharmacy, Fargo,  North Dakota,  58122,  United States
Ohio
      Remington-Davis, Inc., Columbus,  Ohio,  43215,  United States
      St. Vincent Medical Center, Toledo,  Ohio,  43608,  United States
Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18105,  United States
      Medical College of Pennsylvania, Philadelphia,  Pennsylvania,  19129,  United States
      Penn State Clinical Trials Office, Hershey,  Pennsylvania,  17033,  United States
      Department of Anesthesiology and Critical Care Medicine, Pittsburgh,  Pennsylvania,  15261,  United States
      Crozer-Chester Medical Center, Upland,  Pennsylvania,  19013,  United States
      Hahnemann Trauma Research Center, Philadelphia,  Pennsylvania,  19102,  United States
South Carolina
      Medical University of South Carolina and Ralph Johnson VA Medical Center, Charleston,  South Carolina,  29425,  United States
Tennessee
      Methodist Healthcare, Memphis,  Tennessee,  38104,  United States
      Access Clinical Trials, Clarksville,  Tennessee,  37043,  United States
Texas
      Scott and White Hospital, Temple,  Texas,  76508,  United States
Virginia
      Mcguire Research Institute, Richmond,  Virginia,  23249,  United States
      INOVA Fairfax Hospital, Falls Church,  Virginia,  22042,  United States
      International Clinical Research Association, Richmond,  Virginia,  23294,  United States
Washington
      Harborview Medical Center, Seattle,  Washington,  98104,  United States
Canada
      Hopital Hotel Dieu de Quebec and Hopital St Francois D'Assise, Quebec,  G1R 2J6 and G1L 3L5,  Canada
Canada, Alberta
      Foothills Hospital, Peter Lougheed Hospital and Rockyview General Hospital, Calgary,  Alberta,  T2N 1T9,  Canada
Canada, British Columbia
      Vancouver General Hospital, Vancouver,  British Columbia,  V5Z 3J5,  Canada
      St. Paul's Hospital, Providence Health Care, Vancouver,  British Columbia,  V6Z 1Y6,  Canada
Canada, Manitoba
      University of Manitoba, Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R9,  Canada
Canada, New Brunswick
      The Moncton Hospital, Moncton,  New Brunswick,  E1C 6Z8,  Canada
Canada, Ontario
      Hotel-Dieu Grace Hospital and Windsor Regional Hospital, Windsor,  Ontario,  N9A 1C9,  Canada
      Ottawa General Hospital, Ottawa,  Ontario,  K1H 8L6,  Canada
Canada, Quebec
      Centre Hospitalier de la Sagamie, Chicoutimi,  Quebec,  G7H 5H6,  Canada
      Hopital Notre-Dame du CHUM, Departement de microbiologie et infectlologie, Montreal,  Quebec,  H2L 4M1,  Canada
      Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada
      Hospital Maisonneuve Rosemont, Montreal,  Quebec,  H1T 2M4,  Canada
      Montreal General Hospital of the McGill University Health Centre, Montreal,  Quebec,  H2L 4M1,  Canada
      Centre Hospitalier Regional de Trois Rivieres, Trois-Rivieres,  Quebec,  G9A 1Y1,  Canada
Puerto Rico
      International Clinical Research Association, Hato Rey,  00918,  Puerto Rico
United Kingdom
      Gartnavel General Hospital, Glasgow,  G21 3UR,  United Kingdom
      Leeds General Infirmary, Leeds,  LS1 3EX,  United Kingdom
      Leicester Royal Infirmary, Leicester,  LE1 5WW,  United Kingdom
      Birmingham Heartlands Hospital, Department of Infectious Disease, Birmingham,  B95SS,  United Kingdom
      Addenbrooke, Department of Gastroenterology, Cambridge,  CB2 2QQ,  United Kingdom
      City Hospital, Birmingham,  B18 7QH,  United Kingdom
      Hull Royal Infirmary, Hull,  HU3 2JZ,  United Kingdom
      Royal Gwent Hospital, Gastroenterology Unit, Newport,  NP20 2UB,  United Kingdom
      University College London - Department of Gastroenterology, London,  W1N 8AA,  United Kingdom
      Whittington Hospital - Department of Medicine, London,  N19 5LW,  United Kingdom
      Western General Hospital - Regional Infectious Diseases Unit, Edinburgh,  EH4 2XU,  United Kingdom
      Taunton and Somerset Hospital, Taunton,  TA1 5DA,  United Kingdom
      University of Nottingham, Queen's Medical Center, Nottingham,  NG7 2UH,  United Kingdom
      Royal Shrewsbury Hospital, Shrewsbury,  SY3 8XQ,  United Kingdom
      New Cross Hospital - Department of Gastroenterology, Wolverhampton,  WV10 0QP,  United Kingdom
      St. George's Hospital and Medical School, Clinical Infection Unit, London,  SW17 0QT,  United Kingdom
United Kingdom, Cardiff
      University Hospital of Wales, Department of Medicine, Heath Park,  Cardiff,  CF4 4XW,  United Kingdom
      Dept. of Geriatric Medicine, University of Wales College of Medicine, Penlan Rd,  Cardiff,  CF64 2XX,  United Kingdom
United Kingdom, Keighley
      Airedale General Hospital, Department of Elderly Medicine, Steeton,  Keighley,  BD20 6TD,  United Kingdom
United Kingdom, Lancashire
      Fairfield General Hospital, Department of Elderly Medicine, Bury,  Lancashire,  BL9 7TD,  United Kingdom
United Kingdom, London
      Chelsea and Westminster Hospital, Chelsea,  London,  SW10 9NH,  United Kingdom
      Imperial College, School of Medicine, Department of Elderly Medicine, South Kensington,  London,  SW7 2AZ,  United Kingdom
United Kingdom, Newcastle-upon-Tyne
      Freeman Hospital, Department of Gastroenterology, High Heaton,  Newcastle-upon-Tyne,  NE7 7DN,  United Kingdom
United Kingdom, Northampton
      Northampton General Hospital, Cliftonville,  Northampton,  NN1 5BD,  United Kingdom
United Kingdom, Preston
      Royal Preston Hospital, Department of Renal Medicine, Fulwood,  Preston,  PR7 1PP,  United Kingdom
United Kingdom, Stirling
      Stirling Royal Infirmary, Department of Aging Health, Livilands,  Stirling,  FK8 2AU,  United Kingdom
United Kingdom, Swansea
      Morriston Hospital, Morriston,  Swansea,  SA6 6NL,  United Kingdom

Study ID Numbers:  GTC-80-203; GT1105
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  April 24, 2002
ClinicalTrials.gov Identifier:  NCT00034294
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08