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Indomethacin vs Ketorolac for Pancreatitis
Phase 4
Recruiting
Led By David Vitale, MD
Research Sponsored by David Vitale MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial compares the effectiveness of two medications to reduce rates of post-ERCP pancreatitis in children who are having an ERCP.
Who is the study for?
This trial is for children and young adults aged 6 months to 21 years who are scheduled for an ERCP procedure. Participants must not have kidney disease, be pregnant, weigh less than 10 kg, or have a high bleeding risk. They should not have taken NSAIDs recently or have acute pancreatitis at the time of ERCP.Check my eligibility
What is being tested?
The study compares rectal indomethacin with IV ketorolac in preventing post-ERCP pancreatitis in pediatric patients. It's the first study of its kind in this age group and aims to determine which medication is more effective at reducing PEP rates after the procedure.See study design
What are the potential side effects?
Possible side effects include allergic reactions to either drug, gastrointestinal issues like ulcers due to their nature as NSAIDs, potential bleeding complications especially if there's a history of peptic ulcer disease or recent GI bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-ERCP Pancreatitis
Secondary outcome measures
C-Reactive Protein (CRP) level
Hematocrit
Hemoglobin
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Rectal indomethacinExperimental Treatment1 Intervention
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Group II: IV ketorolacExperimental Treatment1 Intervention
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IV ketorolac
2023
Completed Phase 4
~380
Find a Location
Who is running the clinical trial?
David Vitale MDLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
David VitaleLead Sponsor
David Vitale, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken NSAIDs in the last 5 days.I have organ dysfunction or a systemic inflammatory response.I am currently on lithium therapy.I weigh less than 10 kg.I have had gastrointestinal bleeding in the last 3 days.I have been diagnosed with peptic ulcer disease.I am at high risk for bleeding due to a planned procedure.I have a biliary condition and have had a previous biliary sphincterotomy.I am scheduled for or have had an ERCP procedure.I have kidney problems, either sudden or long-term.I have had acute pancreatitis within the last 3 days.I am between 6 months and 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Rectal indomethacin
- Group 2: IV ketorolac
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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