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

Sponsor:	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

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 GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Potassium

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Tolevamer Potassium Sodium Metronidazole Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

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 138 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:	NCT00196794 History of Changes
Other Study ID Numbers:	GD3-170-302
Study First Received:	September 13, 2005
Last Updated:	July 29, 2009
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

Additional relevant MeSH terms:

Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections

Bacterial Infections
Metronidazole
Vancomycin
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012