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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 is a Phase 3 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 65 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2007-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00466635
The ClinicalTrials.gov registry entry for NCT00466635 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GT267-004 (tolevamer potassium sodium) is the first listed.
NCT00466635 reports 0 study locations.
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.
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