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NCT05664074 · ClinicalTrials.gov registry record · Phase 4
Rectal Indomethacin vs Intravenous Ketorolac
A Phase 4 study, sponsored by David Vitale MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 192
- Enrollment target
NCT05664074: Completed Phase 4 study, sponsored by David Vitale MD.
NCT05664074 is a Phase 4 study that has completed, run by David Vitale MD. The registered enrollment target is 192 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05664074, a Phase 4 study, has completed, sponsored by David Vitale MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 192 participants
- Enrollment target
Study Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.
Primary Outcome
Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed Post-ERCP Pancreatitis- Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis: 1. Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea 2. Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal. * Normal range of a
Interventions
- DRUG IV ketorolac
- DRUG Rectal indomethacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2022-11-07 |
| Est. Completion | 2025-02-05 |
| Phase | Phase 4 |
What the finished NCT05664074 record still lists
NCT05664074 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which IV ketorolac is the first listed.
NCT05664074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05664074 about?
NCT05664074 is a clinical study titled "Rectal Indomethacin vs Intravenous Ketorolac". Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing...
What is the current status of trial NCT05664074?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 192 participants. The study started on 2022-11-07. Estimated completion is 2025-02-05.
What interventions are being tested in trial NCT05664074?
The interventions under investigation include: IV ketorolac (DRUG), Rectal indomethacin (DRUG).
Who is sponsoring clinical trial NCT05664074?
This trial is sponsored by David Vitale MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05664074's enrollment target sits among peer trials
192 451st of 2000 higher than 1,548 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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