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NCT00366249 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,061
- Enrollment target
NCT00366249: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00366249 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 1,061 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00366249, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,061 participants
- Enrollment target
Study Summary
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
Primary Outcome
Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) \> 48 hrs.
Interventions
- DRUG Ertapenem
- DRUG Tigecycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,061 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00366249 record still lists
NCT00366249 is an interventional study that assigns participants to a tested intervention. Its 1,061 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Ertapenem is the first listed.
NCT00366249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00366249 about?
NCT00366249 is a clinical study titled "Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.". The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
What is the current status of trial NCT00366249?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,061 participants. The study started on 2007-01. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00366249?
The interventions under investigation include: Ertapenem (DRUG), Tigecycline (DRUG).
Who is sponsoring clinical trial NCT00366249?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00366249's enrollment target sits among peer trials
1,061 275th of 2000 higher than 1,726 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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