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NCT01281462 · ClinicalTrials.gov registry record · Phase 2
Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
NCT01281462: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT01281462 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01281462, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
Study Summary
This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
Primary Outcome
The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)
Interventions
- DRUG Placebo
- DRUG Doripenem
- DRUG Ceftaroline fosamil and NXL104 (q8h)
- DRUG Ceftaroline fosamil and NXL104 (q12h)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01281462 record still lists
NCT01281462 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01281462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01281462 about?
NCT01281462 is a clinical study titled "Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections". This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
What is the current status of trial NCT01281462?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2010-12. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01281462?
The interventions under investigation include: Placebo (DRUG), Doripenem (DRUG), Ceftaroline fosamil and NXL104 (q8h) (DRUG), Ceftaroline fosamil and NXL104 (q12h) (DRUG).
Who is sponsoring clinical trial NCT01281462?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01281462's enrollment target sits among peer trials
217 286th of 2000 higher than 1,715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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