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

An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00466635

Enrollment

Registered

2007-04-27

Start date

2007-04-30

Completion date

2007-08-31

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile, Diarrhea, Enterocolitis, Pseudomembranous

Keywords

Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Clostridium difficile

Brief 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.

Interventions

DRUGGT267-004 (tolevamer potassium sodium)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Clinical Success	—
Safety	—

Secondary

Measure	Time frame
The extent of tolevamer absorption	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026