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

Pseudomembranous Colitis Clinical Trial

Official title:

A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106509
• Other study ID #: GD3-170-301
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2005
• Last updated: March 4, 2015
• Start date: March 2005
• Est. completion date: February 2007

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• 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

Study Design

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

Related Conditions & MeSH terms

• Clostridium Enterocolitis
• Diarrhea
• Enterocolitis
• Enterocolitis, Pseudomembranous
• Pseudomembranous Colitis

Intervention

Drug:
• tolevamer potassium-sodium (GT267-004)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of diarrhea
Secondary	Time to resolution of diarrhea
Secondary	Recurrence rate
Secondary	Number of stools
Secondary	Average stool consistency
Secondary	Treatment success