Ketotifen for Childhood Indigestion

(Ketotifen Trial)

Overseen by Craig A Friesen, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Mercy Hospital Kansas City

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Craig A Friesen, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

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.

Inclusion Criteria

Evidence of written parental permission (consent) and subject assent

Negative pregnancy screening for females of childbearing potential

Previous endoscopy with biopsies demonstrating >20 eosinophils/high powered field on duodenal mucosal biopsies

Exclusion Criteria

I am a woman of childbearing age and do not use effective birth control.

Allergy to ketotifen or other products in capsule

I have not taken corticosteroids or cromolyn sodium in the last 4 weeks.

Treatment Details

Interventions

• Ketotifen (Mast Cell Stabilizer)

Trial Overview 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.

Participant Groups

Group I: cross-over of Ketotifen Active Control 1 Intervention

Patients will begin the active ketotifen treatment first and cross over to placebo.

Group II: cross-over of Placebo Placebo Group 1 Intervention

Patients will begin the placebo treatment first and cross over to the active ketotifen.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+