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NCT00466635 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Genzyme, a Sanofi Company.

Terminated
Registry status
Phase 3
Development phase
65
Enrollment target

NCT00466635: Clinical Trial Phase 3 study, sponsored by Genzyme, a Sanofi Company.

NCT00466635 is a Phase 3 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00466635, a Phase 3 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.

TERMINATED
Registry status
Phase 3
Development phase
65 participants
Enrollment target

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.

Interventions

  • DRUG GT267-004 (tolevamer potassium sodium)

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2007-04
Est. Completion 2007-08
Phase Phase 3
Genzyme, a Sanofi Company

196 total trials

Why NCT00466635 stopped before completion

NCT00466635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which GT267-004 (tolevamer potassium sodium) is the first listed.

NCT00466635 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00466635 about?

NCT00466635 is a clinical study titled "A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea". 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 v...

What is the current status of trial NCT00466635?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2007-04. Estimated completion is 2007-08.

What interventions are being tested in trial NCT00466635?

The interventions under investigation include: GT267-004 (tolevamer potassium sodium) (DRUG).

Who is sponsoring clinical trial NCT00466635?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00466635's enrollment target sits among peer trials

65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00466635, the US trial registry maintained by the National Library of Medicine. NCT00466635 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.