Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Craig A. Friesen, MD
Study ID
NCT02484248
Phase
PHASE3
Status
Recruiting
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Conditions

  • Functional Dyspepsia

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketotifen — DRUG
    Ketotifen is an anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.
  • Placebo — DRUG
    The placebo tablet looks identical to the ketotifen tablet, but does not contain ketotifen.

Study Details

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.

Key Dates

Start date
Aug 31, 2015
Status verified
Jan 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Complete Physical [ Time Frame: day 0, day 28, day 63, and day 147 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Mercy HospitalKansas CityMissouri64108
Amber Bagherian, MS
[email protected]
816-234-3066
Craig A Friesen, MD (PRINCIPAL_INVESTIGATOR)
Jennifer Colombo, MD (SUB_INVESTIGATOR)
Jennifer V Schurman, PhD (SUB_INVESTIGATOR)
Amanda D Deacy, PhD (SUB_INVESTIGATOR)
Susan Abdel-Rahman, PharmD (SUB_INVESTIGATOR)

Find similar trials in Kansas City, MO

By research site
The Children's Mercy Hospital· Kansas City, MO

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