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NCT00106509 · ClinicalTrials.gov registry record · Phase 3
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 520
- Enrollment target
NCT00106509: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00106509 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 520 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106509, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 520 participants
- Enrollment target
Study Summary
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.
Interventions
- DRUG tolevamer potassium-sodium (GT267-004)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
What the finished NCT00106509 record still lists
NCT00106509 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which tolevamer potassium-sodium (GT267-004) is the first listed.
NCT00106509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00106509 about?
NCT00106509 is a clinical study titled "A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea". Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The i...
What is the current status of trial NCT00106509?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2005-03. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00106509?
The interventions under investigation include: tolevamer potassium-sodium (GT267-004) (DRUG).
Who is sponsoring clinical trial NCT00106509?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00106509's enrollment target sits among peer trials
520 717th of 2000 higher than 1,278 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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