Recruiting
Phase 3

Ketotifen

Sponsor:

Craig A. Friesen, MD

Code:

NCT02484248

Conditions

Functional Dyspepsia

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Ketotifen

Placebo

Study Details

Brief summary:

Acid reduction remains the most common treatment prescribed empirically by pediatric gastroenterologists for children with functional dyspepsia (FD). When acid reduction therapy fails to provide patients with a therapeutic effect, ketotifen and cromolyn, mast cell stabilizers, represent an attractive potential therapy given data implicating mast cells in the generation of dyspeptic symptoms. Although there have been no adult or pediatric studies on the use of mast cell stabilizers in patients with FD, benefit has been demonstrated in adults with IBS and children with eosinophilic gastroenteritis. Additionally, previous studies show mucosal eosinophilia is highly correlated with functional dyspepsia. Our usual current treatment pathway for functional dyspepsia in association with duodenal mucosal eosinophilia is as follows: acid-reducing medication/montelukast → addition of H1 antagonist → addition of budesonide → addition of oral cromolyn. If ketotifen is effective, it offers the advantage of being able to replace both the H1 antagonist and the oral cromolyn at a substantially reduced cost (approximately 10% of the cost of cromolyn alone). This study aims to introduce ketotifen earlier in the treatment pathway to examine its efficacy on children with functional dyspepsia in association with duodenal eosinophilia.

Conditions

Functional Dyspepsia

Study ID

NCT02484248

Start date

Aug, 2015

Status verified date

Jan, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. between the ages of 8 and 17 years, inclusive
2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);
3. previous endoscopy with biopsies demonstrating \>20 eosinophils/high powered field on duodenal mucosal biopsies;
4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;
5. evidence of written parental permission (consent) and subject assent;
6. Negative pregnancy screening for females of child bearing potential.

Exclusion Criteria:

1. previous treatment with ketotifen;
2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment;
3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;
4. Pregnant/planning to become pregnant;
5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;
6. Epilepsy or history of seizures;
7. Liver disease or elevation of liver enzymes;
8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;
9. Allergy to ketotifen or other products in capsule
10. Refusal of Urine pregnancy test in post-menarchal females.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: cross-over of Ketotifen

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

placebo comparator: cross-over of Placebo

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

Interventions

Ketotifen

Ketotifen is an anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.

Placebo

The placebo tablet looks identical to the ketotifen tablet, but does not contain ketotifen.

Primary outcome measure

  • Complete Physical [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • Blood pressure [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning) [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • State-Trait Inventory for Cognitive and Somatic Anxiety - Child Version [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • Pediatric Quality of Life Inventory [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • Heart Rate [ Time Frame: day 0, day 28, day 63, and day 147 ]
  • Respiratory Rate [ Time Frame: day 0, day 28, day 63, and day 147 ]

Central Contacts and Locations

Central contacts

Craig A Friesen, M.D.

816-234-3066cfriesen@cmh.edu

Amber Bagherian, MS

816-234-3066abagherian@cmh.edu

Locations

The Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Amber Bagherian, MS

816-234-3066abagherian@cmh.edu

Principal Investigator:

Craig A Friesen, MD

More Information

Sponsor

Craig A. Friesen, MD

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • pediatric
  • eosinophilia
  • duodenal
  • ketotifen
  • functional dyspepsia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Craig A. Friesen, MD on 2026-01-09.