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NCT01110382 · ClinicalTrials.gov registry record · Phase 3
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT01110382: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT01110382 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110382, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
Primary Outcome
The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.
Interventions
- DRUG Meropenem
- DRUG Doripenem
- DRUG Doripenem placebo
- DRUG Amoxicillin/clavulanate potassium
- DRUG Meropenem placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
Why NCT01110382 stopped before completion
NCT01110382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Meropenem is the first listed.
NCT01110382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01110382 about?
NCT01110382 is a clinical study titled "A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections". The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
What is the current status of trial NCT01110382?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2010-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01110382?
The interventions under investigation include: Meropenem (DRUG), Doripenem (DRUG), Doripenem placebo (DRUG), Amoxicillin/clavulanate potassium (DRUG), Meropenem placebo (DRUG).
Who is sponsoring clinical trial NCT01110382?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01110382's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 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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