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NCT00727740 · ClinicalTrials.gov registry record · NA
A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT00727740 is a NA study that has completed, run by Yale University. The registered enrollment target is 117 participants.
The verdict
NCT00727740, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if indomethacin, an anti-inflammatory medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs) can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP, patients will be randomized to receive a dose of indomethacin or placebo (an inactive substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All patients will be observed for 4 hours following ERCP which is part of routine clinical practice. Patients with minimal pain will be discharged after this 4 hour observation period. All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after the ERCP has been completed. Patients who have significant abdominal pain will be hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by telephone the following day to ask them if they have had any complications of ERCP.
Interventions
- DRUG Indomethacin
- DRUG Placebo suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00727740
The ClinicalTrials.gov registry entry for NCT00727740 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Indomethacin is the first listed.
NCT00727740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00727740 about?
NCT00727740 is a clinical study titled "A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis". The purpose of this research study is to determine if indomethacin, an anti-inflammatory medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs) can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography (ERCP.) The hypothesis is th...
What is the current status of trial NCT00727740?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2005-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00727740?
The interventions under investigation include: Indomethacin (DRUG), Placebo suspension (DRUG).
Who is sponsoring clinical trial NCT00727740?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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