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

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Genzyme

Status and phase

Terminated
Phase 3

Conditions

Enterocolitis, Pseudomembranous
Diarrhea
Clostridium Difficile

Treatments

Drug: GT267-004 (tolevamer potassium sodium)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00466635
TOL26700706

Details and patient eligibility

About

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.

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The presence of CDAD at the time of enrollment
  • Negative serum pregnancy test (HCG) for women of childbearing potential.

Exclusion criteria

  • Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
  • Any acutely life-threatening medical conditions.
  • Acute or chronic diarrhea of other cause.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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