NCT02484248 Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 40 participants in total. It began in 2015-08 with a primary completion date of 2027-04-01.

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.

Eligibility Criteria

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.

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