cross-over of Ketotifen for Indigestion

Phase-Based Progress Estimates
The Children's Mercy Hospital, Kansas City, MOIndigestionKetotifen - Drug
8 - 17
All Sexes
What conditions do you have?

Study Summary

This trial is testing whether ketotifen, a mast cell stabilizer, is effective in treating functional dyspepsia (FD), a common childhood stomach disorder. Acid reduction is the most common FD treatment, but when it fails, ketotifen may be an effective alternative.

Eligible Conditions
  • Indigestion

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

7 Primary · 2 Secondary · Reporting Duration: day 0, day 28, day 63, and day 147

Day 147
Blood pressure
Complete Physical
Heart Rate
Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning)
Pediatric Quality of Life Inventory
Pharmacokinetic Sampling (Area under the plasma concentration versus time curve - AUC)
Pharmacokinetics Sampling (Peak Plasma Concentration - Cmax)
Respiratory Rate
State-Trait Inventory for Cognitive and Somatic Anxiety - Child Version

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

cross-over of Ketotifen
1 of 2
cross-over of Placebo
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: cross-over of Ketotifen · Has Placebo Group · Phase 3

cross-over of Ketotifen
ActiveComparator Group · 1 Intervention: Ketotifen · Intervention Types: Drug
cross-over of Placebo
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 0, day 28, day 63, and day 147

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
226 Previous Clinical Trials
1,269,615 Total Patients Enrolled
Craig A Friesen, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
2 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 8 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have taken medication to reduce stomach acid or montelukast before, but it did not work well enough (level 3 or lower response).
You have been experiencing stomach pain for 8 weeks or more and are diagnosed with functional dyspepsia based on specific symptoms.

Frequently Asked Questions

What are Ketotifen's most common indications?

"Ketotifen can be used to provide relief for seasonal allergic conjunctivitis, allergic conjunctivitis (ac), and other eye allergies." - Anonymous Online Contributor

Unverified Answer

Can elderly patients over the age of seventy-five participate in this research?

"In order to take part in this research, volunteers must be aged between 8 and 17. There are 11 other similar trials for minors and 33 for elderly patients." - Anonymous Online Contributor

Unverified Answer

How many total individuals are included in this research project?

"Yes, the information on suggests that this trial is presently recruiting candidates. The clinical trial was first posted on 8/1/2015 and was last edited on 10/10/2022. The trial is looking for 40 participants across 1 locations." - Anonymous Online Contributor

Unverified Answer

Are there any other investigations that have looked into Ketotifen's ability to be effective across different treatments?

"Currently, there are 3 clinical trials testing Ketotifen's efficacy through a cross-over design. Of those, 3 are in Phase 3. Most trials are being conducted in Burlington, Vermont, but 20 other locations across the United States are also running similar trials." - Anonymous Online Contributor

Unverified Answer

Is Ketotifen cross-over dangerous for people?

"There is some efficacy data and multiple rounds of safety data supporting the use of Ketotifen in this Phase 3 trial, so our team at Power has rated the safety of this drug as a 3." - Anonymous Online Contributor

Unverified Answer

Are new patients currently being accepted into this clinical trial?

"Yes, correct. The clinical trial is still looking for participants and was last updated on October 10th, 2022. The study was first posted on August 1st, 2015 and is looking for a total of 40 individuals from 1 site." - Anonymous Online Contributor

Unverified Answer

May I join this investigation if I meet the requirements?

"This study is searching for young patients, aged 8-17, that have eosinophilia and abdominal pain lasting for at least 8 weeks. The ideal candidate also must have had a previous endoscopy with biopsies that showed eosinophils in the duodenum, as well as treatment with acid-reduction therapy and montelukast that didn't produce the desired results." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.