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NCT00195351 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
A Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 467
- Enrollment target
NCT00195351 is a Phase 4 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 467 participants.
The verdict
NCT00195351, a Phase 4 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 467 participants
- Enrollment target
Study Summary
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score \< 10 and \> 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Interventions
- DRUG tigecycline
- DRUG ceftriaxone sodium + metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00195351
The ClinicalTrials.gov registry entry for NCT00195351 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 467 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which tigecycline is the first listed.
NCT00195351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00195351 about?
NCT00195351 is a clinical study titled "Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection". This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be include...
What is the current status of trial NCT00195351?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 467 participants. The study started on 2005-09. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00195351?
The interventions under investigation include: tigecycline (DRUG), ceftriaxone sodium + metronidazole (DRUG).
Who is sponsoring clinical trial NCT00195351?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
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