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NCT01377441 · ClinicalTrials.gov registry record · Phase 4
Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.
A Phase 4 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT01377441: Clinical Trial Phase 4 study, sponsored by NYU Langone Health.
NCT01377441 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377441, a Phase 4 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.
Primary Outcome
Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.
Interventions
- DRUG Ibuprofen
- DRUG Placebo/Saline solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
Why NCT01377441 stopped before completion
NCT01377441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen is the first listed.
NCT01377441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377441 about?
NCT01377441 is a clinical study titled "Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.". The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. I...
What is the current status of trial NCT01377441?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2011-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01377441?
The interventions under investigation include: Ibuprofen (DRUG), Placebo/Saline solution (DRUG).
Who is sponsoring clinical trial NCT01377441?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01377441's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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