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

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)