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

This study has been completed.

First Received: April 24, 2002 Last Updated: July 29, 2009 History of Changes

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00034294

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Diarrhea

Drug Information available for: Vancomycin

U.S. FDA Resources

Further study details as provided by Genzyme:

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

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

Show 100 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

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

Keywords provided by Genzyme:

C. difficile-associated diarrhea
CDAD
Clostridium difficile-Associated Diarrhea
Clostridium enterocolitis
antibiotic-associated diarrhea

clostridium difficile colitis
infectious diarrhea
chronic diarrhea
antibiotic-associated colitis

Study placed in the following topic categories:

Bacterial Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Clostridium Difficile
Enterocolitis, Pseudomembranous
Intestinal Diseases
Enterocolitis

Anti-Bacterial Agents
Signs and Symptoms
Gram-Positive Bacterial Infections
Digestive System Diseases
Dysentery
Vancomycin
Gastroenteritis
Clostridium Infections
Colitis

Additional relevant MeSH terms:

Bacterial Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Intestinal Diseases

Enterocolitis
Signs and Symptoms
Gram-Positive Bacterial Infections
Digestive System Diseases
Gastroenteritis
Clostridium Infections
Colitis

ClinicalTrials.gov processed this record on September 11, 2009