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

NCT ID: NCT00034294

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Clostridium Difficile-Associated Diarrhea Clostridium Enterocolitis Clostridium Difficile Diarrhea Antibiotic-associated Colitis Antibiotic-associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GT160-246

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Sacramento, California, United States

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Newark, Delaware, United States

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Bay Pines, Florida, United States

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Brandon, Florida, United States

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Hollywood, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Austell, Georgia, United States

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Columbus, Georgia, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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North Chicago, Illinois, United States

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Columbus, Indiana, United States

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Des Moines, Iowa, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Boston, Massachusetts, United States

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Braintree, Massachusetts, United States

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West Roxbury, Massachusetts, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Stratford, New Jersey, United States

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Buffalo, New York, United States

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Jamaica, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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New York, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Fargo, North Dakota, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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Clarksville, Tennessee, United States

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Memphis, Tennessee, United States

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Temple, Texas, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Ottawa, Ontario, Canada

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Windsor, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Hato Rey, , Puerto Rico

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Heathpark, Cardiff, United Kingdom

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Penlan Rd, Cardiff, United Kingdom

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Steeton, Keighley, United Kingdom

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Bury, Lancashire, United Kingdom

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Chelsea, London, United Kingdom

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South Kensington, London, United Kingdom

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High Heaton, Newcastle-upon-Tyne, United Kingdom

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Cliftonville, Northampton, United Kingdom

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Fulwood, Preston, United Kingdom

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Livilands, Stirling, United Kingdom

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Morriston, Swansea, United Kingdom

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Cambridge, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Hull, , United Kingdom

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Leeds, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Newport, , United Kingdom

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Nottingham, , United Kingdom

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Shrewsbury, , United Kingdom

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Taunton, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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United States Canada Puerto Rico United Kingdom

Other Identifiers

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GT1105

Identifier Type: -

Identifier Source: secondary_id

GTC-80-203

Identifier Type: -

Identifier Source: org_study_id

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