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Mast Cell Stabilizer

Ketotifen for Childhood Indigestion (Ketotifen Trial)

Phase 3
Waitlist Available
Led By Craig A Friesen, 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
Previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below) or lesser response
Ages between 8 and 17 years
Must not have
Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy
Liver disease or elevation of liver enzymes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 28, day 63, and day 147
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial tests ketotifen, a medication that stabilizes certain immune cells, in children aged 8-17 with functional dyspepsia who haven't responded to standard treatments. Ketotifen aims to reduce inflammation and pain by preventing these cells from releasing harmful substances.

Who is the study for?
This trial is for children aged 8-17 with functional dyspepsia and duodenal eosinophilia, who've had little to no relief from acid-reduction therapy and montelukast. They must have had a previous endoscopy showing specific levels of eosinophils. Kids can't join if they're on certain medications like opioids or have liver disease, diabetes, cancer, heart problems, respiratory or kidney diseases.
What is being tested?
The study tests Ketotifen's effectiveness in treating indigestion linked to duodenal eosinophilia in kids who haven't improved with standard treatments. It compares Ketotifen against a placebo to see if it can replace more expensive therapies earlier in the treatment process.
What are the potential side effects?
Ketotifen may cause side effects such as drowsiness, dry mouth, and mild gastrointestinal issues. Since it's being compared to a placebo which has no active ingredients, any additional side effects observed could be attributed to Ketotifen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had little to no improvement from acid-reduction or montelukast treatments.
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I am between 8 and 17 years old.
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I have had stomach pain for at least 8 weeks that fits the symptoms of functional dyspepsia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman of childbearing age and do not use effective birth control.
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I have liver disease or high liver enzymes.
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I refuse to take a urine pregnancy test.
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I have epilepsy or a history of seizures.
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I have been treated with ketotifen before.
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I have a history of diabetes, cancer, heart, lung, or kidney disease needing regular care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 28, day 63, and day 147
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 28, day 63, and day 147 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood pressure
Complete Physical
Heart Rate
+4 more
Secondary study objectives
Pharmacokinetic Sampling (Area under the plasma concentration versus time curve - AUC)
Pharmacokinetics Sampling (Peak Plasma Concentration - Cmax)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: cross-over of KetotifenActive Control1 Intervention
Patients will begin the active ketotifen treatment first and cross over to placebo.
Group II: cross-over of PlaceboPlacebo Group1 Intervention
Patients will begin the placebo treatment first and cross over to the active ketotifen.

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
256 Previous Clinical Trials
940,295 Total Patients Enrolled
Craig A Friesen, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
2 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Ketotifen (Mast Cell Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT02484248 — Phase 3
Indigestion Research Study Groups: cross-over of Ketotifen, cross-over of Placebo
Indigestion Clinical Trial 2023: Ketotifen Highlights & Side Effects. Trial Name: NCT02484248 — Phase 3
Ketotifen (Mast Cell Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02484248 — Phase 3
~1 spots leftby Mar 2025
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