A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00034294
First received: April 24, 2002
Last updated: July 29, 2009
Last verified: November 2006
  Purpose

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 Intervention Phase
Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-Associated Colitis
Antibiotic-Associated Diarrhea
Drug: GT160-246
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Estimated Enrollment: 300
Study Start Date: February 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034294

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36617
United States, Arizona
Phoenix, Arizona, United States, 85006
Tucson, Arizona, United States, 85724
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Sacramento, California, United States, 95816
United States, Delaware
Newark, Delaware, United States, 19718
United States, Florida
Bay Pines, Florida, United States, 33744
Brandon, Florida, United States, 33511
Hollywood, Florida, United States, 33021
Naples, Florida, United States, 34102
Orlando, Florida, United States, 32806
United States, Georgia
Austell, Georgia, United States, 30106
Columbus, Georgia, United States, 31902
United States, Illinois
Chicago, Illinois, United States, 60611
Maywood, Illinois, United States, 60153
North Chicago, Illinois, United States, 60064
United States, Indiana
Columbus, Indiana, United States, 47203
United States, Iowa
Des Moines, Iowa, United States, 50309
Des Moines, Iowa, United States, 50314
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Lexington, Kentucky, United States, 40536-0084
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore, Maryland, United States, 21215
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Braintree, Massachusetts, United States, 02185
West Roxbury, Massachusetts, United States, 02132
United States, Missouri
Springfield, Missouri, United States, 65807
St. Louis, Missouri, United States, 63110
United States, New Jersey
Stratford, New Jersey, United States, 08084
United States, New York
Buffalo, New York, United States, 14215
Jamaica, New York, United States, 11432
Manhasset, New York, United States, 11030
New York, New York, United States, 10032
New York, New York, United States, 10010
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28801
Charlotte, North Carolina, United States, 28203
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Columbus, Ohio, United States, 43215
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18105
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19129
Pittsburgh, Pennsylvania, United States, 15261
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Clarksville, Tennessee, United States, 37043
Memphis, Tennessee, United States, 38104
United States, Texas
Temple, Texas, United States, 76508
United States, Virginia
Falls Church, Virginia, United States, 22042
Richmond, Virginia, United States, 23249
Richmond, Virginia, United States, 23294
United States, Washington
Seattle, Washington, United States, 98104
Canada, Alberta
Calgary, Alberta, Canada, T2N 1T9
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 3J5
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Windsor, Ontario, Canada, N9A 1C9
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H1T 2M4
Trois-Rivieres, Quebec, Canada, G9A 1Y1
Canada
Quebec, Canada, G1R 2J6 and G1L 3L5
Puerto Rico
Hato Rey, Puerto Rico, 00918
United Kingdom
Heath Park, Cardiff, United Kingdom, CF4 4XW
Penlan Rd, Cardiff, United Kingdom, CF64 2XX
Steeton, Keighley, United Kingdom, BD20 6TD
Bury, Lancashire, United Kingdom, BL9 7TD
Chelsea, London, United Kingdom, SW10 9NH
South Kensington, London, United Kingdom, SW7 2AZ
High Heaton, Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Cliftonville, Northampton, United Kingdom, NN1 5BD
Fulwood, Preston, United Kingdom, PR7 1PP
Livilands, Stirling, United Kingdom, FK8 2AU
Morriston, Swansea, United Kingdom, SA6 6NL
Birmingham, United Kingdom, B18 7QH
Birmingham, United Kingdom, B95SS
Cambridge, United Kingdom, CB2 2QQ
Edinburgh, United Kingdom, EH4 2XU
Glasgow, United Kingdom, G21 3UR
Hull, United Kingdom, HU3 2JZ
Leeds, United Kingdom, LS1 3EX
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, N19 5LW
London, United Kingdom, SW17 0QT
London, United Kingdom, W1N 8AA
Newport, United Kingdom, NP20 2UB
Nottingham, United Kingdom, NG7 2UH
Shrewsbury, United Kingdom, SY3 8XQ
Taunton, United Kingdom, TA1 5DA
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00034294     History of Changes
Other Study ID Numbers: GTC-80-203, GT1105
Study First Received: April 24, 2002
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
C. difficile-associated diarrhea
CDAD
Clostridium difficile-Associated Diarrhea
Clostridium enterocolitis
antibiotic-associated diarrhea
clostridium difficile colitis
infectious diarrhea
chronic diarrhea
antibiotic-associated colitis

Additional relevant MeSH terms:
Colitis
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Bacterial Infections
Clostridium Infections
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Gram-Positive Bacterial Infections
Intestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 30, 2014