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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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 that 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 7 days.

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Detailed Description

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Conditions

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Pseudomembranous Colitis Clostridium Difficile Diarrhea Antibiotic-Associated Diarrhea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tolevamer potassium-sodium (GT267-004)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No