Ketotifen for Childhood Indigestion
(Ketotifen Trial)
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot participate if you've used oral corticosteroids or oral cromolyn sodium in the past 6 months, or if you're taking certain medications like antipsychotics or opioids.
What data supports the effectiveness of the drug Ketotifen for childhood indigestion?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to receive either ketotifen or placebo in a cross-over design, with each treatment lasting 28 days.
Open-label extension
Initial ketotifen responders undergo an open-label twelve-week trial of ketotifen to assess sustainability.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of heart rate, liver function, and quality of life.
Treatment Details
Interventions
- Ketotifen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor