A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
NCT ID: NCT00106509
Last Updated: 2015-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2005-03-31
2007-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
NCT00196794
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
NCT00382304
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
NCT00034294
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
NCT01346059
Secondary Prevention of Clostridioides Difficile Using Vancomycin
NCT06979609
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tolevamer potassium-sodium (GT267-004)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete a 6 week study period
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Genzyme Corporation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Rogers, Arkansas, United States
Burbank, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Modesto, California, United States
Newport Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Newark, Delaware, United States
Bay Pines, Florida, United States
Brandon, Florida, United States
Brooksville, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Fort Eisenhower, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Hines, Illinois, United States
Maywood, Illinois, United States
North Chicago, Illinois, United States
Anderson, Indiana, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Muncie, Indiana, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Dubuque, Iowa, United States
Iowa City, Iowa, United States
Bowling Green, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Muskegon, Michigan, United States
Rochester, Minnesota, United States
Ocean Springs, Mississippi, United States
Everton, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Missoula, Montana, United States
Lebanon, New Hampshire, United States
Cedar Knolls, New Jersey, United States
Neptune City, New Jersey, United States
Newark, New Jersey, United States
Trenton, New Jersey, United States
Albany, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Centerville, Ohio, United States
Toledo, Ohio, United States
Allentown, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Rapid City, South Dakota, United States
Hermitage, Tennessee, United States
Houston, Texas, United States
Tyler, Texas, United States
Burlington, Vermont, United States
Danville, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Winchester, Virginia, United States
Tacoma, Washington, United States
Eau Claire, Wisconsin, United States
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Ajax, Ontario, Canada
Guelph, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Scarborough Village, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Windsor, Ontario, Canada
Chicoutimi, Quebec, Canada
Green Field Park, Quebec, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Saint-Hyacinthe, Quebec, Canada
Sainte-Foy, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GD3-170-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.