A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00196794

Purpose

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. 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. The total length of participation is approximately 6 weeks.

Condition	Intervention	Phase
Clostridium Enterocolitis Diarrhea	Drug: Tolevamer potassium-sodium (GT267-004)	Phase III

MedlinePlus related topics: Diarrhea

Drug Information available for: Vancomycin Metronidazole Metronidazole hydrochloride Metronidazole phosphate Potassium chloride Vancomycin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Further study details as provided by Genzyme:

Primary Outcome Measures:

Resolution of diarrhea

Secondary Outcome Measures:

Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success

Enrollment:	520
Study Start Date:	April 2005
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age and above
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 6 week study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196794

Show 140 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:	David Davidson, M.D.	Genzyme
Study Director:	Gerard Short, MB, BS	Genzyme Corporation, Europe

More Information

Study ID Numbers:	GD3-170-302
Study First Received:	September 13, 2005
Last Updated:	August 17, 2007
ClinicalTrials.gov Identifier:	NCT00196794
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Genzyme:

Pseudomembranous Colitis
Clostridium difficile-associated diarrhea
C. difficile
CDAD

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009