TOL26700606: A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00382304

Purpose

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition 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 7days.

Condition	Intervention	Phase
Pseudomembranous Colitis Clostridium Difficile-Associated Diarrhea Antibiotic-Associated Diarrhea	Drug: tolevamer potassium-sodium (GT267-004)	Phase II

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Official Title: A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Further Study Details:

Primary Outcomes: The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis.

Secondary Outcomes: Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values.

Expected Total Enrollment: 24

Study start: Sept 2006

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

18 years of age or older

The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria:

>72 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specifically targeting the current acute episode of CDAD

Patient not considered sufficiently stable clinically to complete the study period

Location and Contact Information

Central Contact:

Canada, Alberta
Edmonton, Alberta, T6G 2B7, Canada; Recruiting

Canada, British Columbia
Nanaimo, British Columbia, V9S 2B7, Canada; Recruiting
Vancouver, British Columbia, V3Z 1M9, Canada; Recruiting

Canada, Ontario
Richmond Hill, Ontario, L4C 4Z3, Canada; No longer recruiting
Ottowa, Ontario, K1H 8L6, Canada; Recruiting

Canada, Quebec
Rimouski, Quebec, G5L 5T1, Canada; Recruiting
Sherbrooke, Quebec, J1H 5N4, Canada; Recruiting
Montreal, Quebec, H3T 1E2, Canada; Recruiting

More Information

Study ID Numbers: TOL26700606
ClinicalTrials.gov Identifier: NCT00382304
Health Authority: United States - FDA; Canada - Health Canada