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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Vancomycin hydrochloride

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 99 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00034294 History of Changes
Other Study ID Numbers:	GTC-80-203, GT1105
Study First Received:	April 24, 2002
Last Updated:	July 29, 2009
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

Additional relevant MeSH terms:

Colitis
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive

Signs and Symptoms
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012