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

Who is this study for? Patients with Functional Dyspepsia
What treatments are being studied? Ketotifen
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
The Children's Mercy Hospital
RECRUITING
Kansas City
Contact Information
Primary
Craig A Friesen, M.D.
cfriesen@cmh.edu
816-234-3066
Backup
Amber Bagherian, MS
abagherian@cmh.edu
816-234-3066
Time Frame
Start Date: 2015-08
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Mercy Hospital Kansas City

This content was sourced from clinicaltrials.gov