Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia
ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-17
SponsorCraig A. Friesen, MD
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
previous treatment with ketotifen;
treatment with oral corticosteroids or oral cromolyn sodium in the 6 months 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;
Trial design
Design model
Crossover
Treatments tested in this trial
Ketotifen
DrugKetotifen is an anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.
Placebo
DrugThe placebo tablet looks identical to the ketotifen tablet, but does not contain ketotifen.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: cross-over of KetotifenActive comparator 1 intervention
Group B: cross-over of PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Complete Physical
The study physician will check all systems and ask questions about pain and symptoms. This is a comprehensive system check to ensure safety. Change is assessed from each time period.
Time frame
day 0, day 28, day 63, and day 1472
Blood pressure
A trained professional will measure blood pressure to ensure value is within normal range and ensure safety of patient. Change is assessed from each time period.
Time frame
day 0, day 28, day 63, and day 1473
Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning)
A blood sample is collected and tested by a certified laboratory for liver function. This will be completed and verified to be within normal ranges by the study physician to ensure patient safety. Change is assessed from each time period.
Time frame
day 0, day 28, day 63, and day 1474
State-Trait Inventory for Cognitive and Somatic Anxiety - Child Version
Anxiety score testing assessed with questionnaires. Anxiety scores are correlated with pain. Change is assessed from each time period.
Time frame
day 0, day 28, day 63, and day 147Secondary outcomes
1
Pharmacokinetic Sampling (Area under the plasma concentration versus time curve - AUC)
Pharmacokinetic sampling allows for evaluation of the entire process of the drug breakdown by the body and ensures long term efficacy and safety. Change is being assessed from each time period.
Time frame
day 0, day 28, day 63, and day 1472
Pharmacokinetics Sampling (Peak Plasma Concentration - Cmax)
Pharmacokinetic sampling allows for evaluation of the entire process of the drug breakdown by the body and ensures long term efficacy and safety. Change is being assessed from each time period.
Time frame
day 0, day 28, day 63, and day 147Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Craig A. Friesen, MD
Lead sponsor
Children's Mercy Hospital Kansas City
Sponsor institution
Source ClinicalTrials.gov