A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
2 other identifiers
interventional
300
4 countries
99
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2002
Shorter than P25 for phase_2
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 24, 2002
CompletedFirst Posted
Study publicly available on registry
April 25, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedMarch 5, 2015
March 1, 2015
April 24, 2002
March 4, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
Unknown Facility
Mobile, Alabama, 36617, United States
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Phoenix, Arizona, 85006, United States
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Tucson, Arizona, 85724, United States
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Little Rock, Arkansas, 72205, United States
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Sacramento, California, 95816, United States
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Newark, Delaware, 19718, United States
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Bay Pines, Florida, 33744, United States
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Brandon, Florida, 33511, United States
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Hollywood, Florida, 33021, United States
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Naples, Florida, 34102, United States
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Orlando, Florida, 32806, United States
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Austell, Georgia, 30106, United States
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Columbus, Georgia, 31902, United States
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Chicago, Illinois, 60611, United States
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Maywood, Illinois, 60153, United States
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North Chicago, Illinois, 60064, United States
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Columbus, Indiana, 47203, United States
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Des Moines, Iowa, 50309, United States
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Des Moines, Iowa, 50314, United States
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Wichita, Kansas, 67214, United States
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Lexington, Kentucky, 40536-0084, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21215, United States
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Chevy Chase, Maryland, 20815, United States
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Boston, Massachusetts, 02111, United States
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Braintree, Massachusetts, 02185, United States
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West Roxbury, Massachusetts, 02132, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63110, United States
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Stratford, New Jersey, 08084, United States
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Buffalo, New York, 14215, United States
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Jamaica, New York, 11432, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10010, United States
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New York, New York, 10032, United States
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Syracuse, New York, 13210, United States
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Asheville, North Carolina, 28801, United States
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Charlotte, North Carolina, 28203, United States
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Fargo, North Dakota, 58122, United States
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Columbus, Ohio, 43215, United States
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Toledo, Ohio, 43608, United States
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Oklahoma City, Oklahoma, 73104, United States
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Allentown, Pennsylvania, 18105, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19129, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15261, United States
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Upland, Pennsylvania, 19013, United States
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Charleston, South Carolina, 29425, United States
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Clarksville, Tennessee, 37043, United States
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Memphis, Tennessee, 38104, United States
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Temple, Texas, 76508, United States
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Falls Church, Virginia, 22042, United States
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Richmond, Virginia, 23249, United States
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Richmond, Virginia, 23294, United States
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Seattle, Washington, 98104, United States
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Calgary, Alberta, T2N 1T9, Canada
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Vancouver, British Columbia, V5Z 3J5, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Windsor, Ontario, N9A 1C9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1R 2J6 and G1L 3L5, Canada
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Trois-Rivières, Quebec, G9A 1Y1, Canada
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Hato Rey, 00918, Puerto Rico
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Heathpark, Cardiff, CF4 4XW, United Kingdom
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Penlan Rd, Cardiff, CF64 2XX, United Kingdom
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Steeton, Keighley, BD20 6TD, United Kingdom
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Bury, Lancashire, BL9 7TD, United Kingdom
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Chelsea, London, SW10 9NH, United Kingdom
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South Kensington, London, SW7 2AZ, United Kingdom
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High Heaton, Newcastle-upon-Tyne, NE7 7DN, United Kingdom
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Cliftonville, Northampton, NN1 5BD, United Kingdom
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Fulwood, Preston, PR7 1PP, United Kingdom
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Livilands, Stirling, FK8 2AU, United Kingdom
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Morriston, Swansea, SA6 6NL, United Kingdom
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Birmingham, B18 7QH, United Kingdom
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Birmingham, B95SS, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G21 3UR, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Leeds, LS1 3EX, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, N19 5LW, United Kingdom
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London, SW17 0QT, United Kingdom
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London, W1N 8AA, United Kingdom
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Newport, NP20 2UB, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Shrewsbury, SY3 8XQ, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2002
First Posted
April 25, 2002
Study Start
February 1, 2002
Study Completion
July 1, 2003
Last Updated
March 5, 2015
Record last verified: 2015-03