Clinical trial NCT00034294: A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Official title: A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-associated Colitis
Antibiotic-associated Diarrhea
Keywords: C. difficile-associated diarrhea
CDAD
Clostridium difficile-Associated Diarrhea
Clostridium enterocolitis
antibiotic-associated diarrhea
clostridium difficile colitis
infectious diarrhea
chronic diarrhea
antibiotic-associated colitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Sacramento
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Bay Pines
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Austell
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Columbus
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Chevy Chase
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Braintree
country: United States
state: Massachusetts
city: West Roxbury
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Stratford
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Clarksville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Temple
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: Ottawa
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Hato Rey
country: Puerto Rico
city: Heath Park
country: United Kingdom
state: Cardiff
city: Penlan Rd
country: United Kingdom
state: Cardiff
city: Steeton
country: United Kingdom
state: Keighley
city: Bury
country: United Kingdom
state: Lancashire
city: Chelsea
country: United Kingdom
state: London
city: South Kensington
country: United Kingdom
state: London
city: High Heaton
country: United Kingdom
state: Newcastle-upon-Tyne
city: Cliftonville
country: United Kingdom
state: Northampton
city: Fulwood
country: United Kingdom
state: Preston
city: Livilands
country: United Kingdom
state: Stirling
city: Morriston
country: United Kingdom
state: Swansea
city: Birmingham
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Hull
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newport
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Shrewsbury
country: United Kingdom
city: Taunton
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: