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Proton Pump Inhibitor

Proton Pump Inhibitors for Obesity (LiverLabPPI Trial)

Phase 4
Recruiting
Led By Valentina Shakhnovich, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
6-21 years of age
BMI ≥10th percentile for age (6-20 years of age)
Must not have
Exceeds 500lbs or 227 kg in Body Weight
Unable to have blood drawn for the screening lab tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests whether obesity affects how well acid suppression medications work in children.

Who is the study for?
This trial is for children and young adults aged 6-21 with a BMI in the healthy range or higher, who may be generally healthy or have conditions like GERD, NAFLD, chronic abdominal pain, or obesity. Participants can currently be taking pantoprazole or lansoprazole. Those over 500lbs, with significant liver/renal impairment, pregnant/breastfeeding females, individuals with certain infections (hepatitis B/C/HIV), and those unable to undergo MRI due to metal implants are excluded.
What is being tested?
The study investigates how obesity influences the effectiveness of acid suppression drugs in children. It involves administering Midazolam injection and Pantoprazole to observe their pharmacological effects over time in obese versus non-obese participants.
What are the potential side effects?
Potential side effects from Midazolam include drowsiness, dizziness, nausea; while Pantoprazole might cause digestive issues like diarrhea or constipation, headache and potential long-term risks such as vitamin deficiencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 21 years old.
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My BMI is in the healthy range for my age.
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I am over 20 years old with a BMI of at least 18.5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh more than 500lbs or 227kg.
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I cannot have blood drawn for tests.
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I have not had surgery on my stomach or intestines.
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My kidney function is low, with creatinine levels three times higher than normal for my age.
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My liver tests are much higher than normal.
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I do not have hepatitis B, C, or HIV.
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I am pregnant or breastfeeding.
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I cannot or do not want to fast overnight before the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
plasma pharmacokinetics of pantoprazole
Secondary study objectives
pharmacodynamics
pharmacokinetics of midazolam, if medication received to ease discomfort of pH probe study
safety of pantoprazole: incidence of reported and gastrointestinal adverse events
+1 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280
21%
Common cold
5%
Noro virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil (MMF)
MMF + PAN
EC-MPS
EC-MPS + PAN

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Not in Weight Management ProgramExperimental Treatment2 Interventions
Evaluate the effect of liver fat on drug metabolism of PPI's, and if applicable midazolam
Group II: In Weight Management ProgramExperimental Treatment2 Interventions
Evaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pantoprazole
2014
Completed Phase 4
~1500
Midazolam injection
2018
Completed Phase 4
~1460

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,346 Total Patients Enrolled
Valentina Shakhnovich, MD5.02 ReviewsPrincipal Investigator - Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Kathryn Kyler, MD, MSPrincipal InvestigatorChildren's Mercy Hospital Kansas City

Media Library

Pantoprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04248335 — Phase 4
Acid Reflux Research Study Groups: In Weight Management Program, Not in Weight Management Program
Acid Reflux Clinical Trial 2023: Pantoprazole Highlights & Side Effects. Trial Name: NCT04248335 — Phase 4
Pantoprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248335 — Phase 4
~0 spots leftby Dec 2024
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