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A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

NCT00466635 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-03-19

No results posted yet for this study

Summary

Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Conditions

  • Enterocolitis, Pseudomembranous
  • Diarrhea
  • Clostridium Difficile

Interventions

DRUG

GT267-004 (tolevamer potassium sodium)

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466635 on ClinicalTrials.gov