Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

  • STATUS
    Recruiting
  • End date
    Mar 25, 2025
  • participants needed
    40
  • sponsor
    Children's Mercy Hospital Kansas City
Updated on 25 January 2021
endoscopy
abdominal pain
montelukast
budesonide
mast cells
mast cell stabilizers

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.

Description

This study is a double-blind, placebo-controlled, cross-over trial of ketotifen in children ages 8 through 17 inclusive that have a diagnosis of functional dyspepsia and have had continued abdominal pain despite acid reduction therapy in combination with montelukast. The primary aim is to assess the symptomatic response to ketotifen as compared to placebo in children with functional dyspepsia in association with duodenal eosinophilia who have previously had worsening, no clinical change, or only a partial response to acid-reduction therapy in combination with montelukast.

The study lasts 147 days for subjects responsive to ketotifen and 63 days for those who are not. For those who respond to ketotifen, there are 4 clinic visits and 3 phone interviews. Clinic visits include a physical, blood draws, questionnaires, review of medical history and medications; phone interviews involve answering a few questions. For those who do not respond to ketotifen, there are 3 clinic and 2 phone visits. Subjects who enroll in the study are randomly assigned to Group A or Group B. The subject, subject's parents, and study staff will not know to which group the subject is assigned. Group A will be given a placebo, an inactive pill with no medication in it, for days 1-28, and switched to ketotifen for days 36-63. Group B will be given ketotifen for days 1-28 and switched to placebo for days 36-63. The group assignment will be unblinded at day 63, at which point initial ketotifen responders will undergo an open-label twelve week trial of ketotifen to assess sustainability.

Secondary aims of this study include assessing the impact of ketotifen on quality of life, state and trait anxiety, and whether baseline trait anxiety is predictive of clinical response to ketotifen. The study will also assess whether functional dyspepsia subtype is predictive of response to ketotifen, the sustainability of response to ketotifen in initial responders, and the pharmacokinetics of ketotifen in this patient population.

Details
Condition Functional Dyspepsia
Treatment Placebo, Ketotifen
Clinical Study IdentifierNCT02484248
SponsorChildren's Mercy Hospital Kansas City
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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