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

Diarrhea 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: NCT00196794
• Other study ID #: GD3-170-302
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 17, 2014
• Start date: April 2005
• Est. completion date: August 2007

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

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

Eligibility

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.

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

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

Australia,  Austria,  Belgium,  Czech Republic,  Denmark,  France,  Germany,  Ireland,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

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