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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 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 520 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106509
The ClinicalTrials.gov registry entry for NCT00106509 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 520 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 tolevamer potassium-sodium (GT267-004) is the first listed.
NCT00106509 reports 0 study locations.
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.
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