Ketotifen for Childhood Indigestion

(Ketotifen Trial)

Overseen By Amber Bagherian, MS

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Mercy Hospital Kansas City

Must be taking: Acid-reducing, Montelukast

Must not be taking: Corticosteroids, Antipsychotics, Opioids, others

Disqualifiers: Diabetes, Cancer, Cardiac disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 63 days

40 Participants Needed

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?

A study involving 42 allergic children with chronic abdominal complaints showed that Ketotifen had a favorable effect on the digestive tract, suggesting it may help with childhood indigestion. ^{1 2 3 4 5}

Is Ketotifen safe for children?

Ketotifen has been studied in children for various conditions, including allergies and asthma, and is generally considered safe. Some children may experience drowsiness initially, but no serious side effects or laboratory abnormalities have been reported. ^{1 4 5 6 7}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either ketotifen or placebo in a cross-over design, with each treatment lasting 28 days.

63 days

4 clinic visits, 3 phone interviews for responders; 3 clinic visits, 2 phone interviews for non-responders

Open-label extension

Initial ketotifen responders undergo an open-label twelve-week trial of ketotifen to assess sustainability.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of heart rate, liver function, and quality of life.

12 weeks

Treatment Details

Interventions

• Ketotifen

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+

Findings from Research

Proton pump inhibitors (PPIs) like omeprazole and lansoprazole are more effective than histamine-2 receptor antagonists for treating gastroesophageal reflux disease (GERD) in children, with studies showing they effectively relieve symptoms and heal erosive esophagitis.

PPIs have a good safety profile in both adults and children, with minimal clinically significant drug interactions, and can be administered in various forms to accommodate children who have difficulty swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroesophageal reflux in children: pathogenesis, prevalence, diagnosis, and role of proton pump inhibitors in treatment. Gold, BD., Freston, JW.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Ketotifen in the treatment of changes of the upper part of digestive tract in allergic children. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Gastroesophageal reflux disease: could intervention in childhood reduce the risk of later complications? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cimetidine treatment of reflux esophagitis in children: an Italian multicentric study. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Gastroesophageal reflux in children: pathogenesis, prevalence, diagnosis, and role of proton pump inhibitors in treatment. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Ketotifen in African children. [2013]

6. England pubmed.ncbi.nlm.nih.gov

The role of ketotifen in children with recurrent bronchitis. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review. [2022]