RECRUITING

Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Double-blind, Placebo-controlled, Cross-over Trial of Ketotifen in Children and Adolescents With Functional Dyspepsia in Association With Duodenal Eosinophilia

Quick Facts

Study Start:2015-08
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02484248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. between the ages of 8 and 17 years, inclusive
  2. 2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);
  3. 3. previous endoscopy with biopsies demonstrating \>20 eosinophils/high powered field on duodenal mucosal biopsies;
  4. 4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;
  5. 5. evidence of written parental permission (consent) and subject assent;
  6. 6. Negative pregnancy screening for females of child bearing potential.
  1. 1. previous treatment with ketotifen;
  2. 2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment;
  3. 3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;
  4. 4. Pregnant/planning to become pregnant;
  5. 5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;
  6. 6. Epilepsy or history of seizures;
  7. 7. Liver disease or elevation of liver enzymes;
  8. 8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;
  9. 9. Allergy to ketotifen or other products in capsule
  10. 10. Refusal of Urine pregnancy test in post-menarchal females.

Contacts and Locations

Study Contact

Craig A Friesen, M.D.
CONTACT
816-234-3066
cfriesen@cmh.edu
Amber Bagherian, MS
CONTACT
816-234-3066
abagherian@cmh.edu

Principal Investigator

Craig A Friesen, MD
PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City

Study Locations (Sites)

The Children's Mercy Hospital
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Craig A Friesen, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-08
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2015-08
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • pediatric
  • eosinophilia
  • duodenal
  • ketotifen
  • functional dyspepsia

Additional Relevant MeSH Terms

  • Functional Dyspepsia