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NCT02241512 · ClinicalTrials.gov registry record · Phase 2
IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT02241512 is a Phase 2 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 69 participants.
The verdict
NCT02241512, a Phase 2 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.
Interventions
- DRUG placebo
- DRUG Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02241512
The ClinicalTrials.gov registry entry for NCT02241512 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02241512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02241512 about?
NCT02241512 is a clinical study titled "IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis". Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately ...
What is the current status of trial NCT02241512?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2014-09. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02241512?
The interventions under investigation include: placebo (DRUG), Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT02241512?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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