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Mast Cell Stabilizer

Ketotifen for Childhood Indigestion (Ketotifen Trial)

Phase 3

Waitlist Available

Led By Craig A Friesen, MD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below) or lesser response

Ages between 8 and 17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, day 28, day 63, and day 147

Awards & highlights

Ketotifen Trial 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.

Who is the study for?

This trial is for children aged 8-17 with functional dyspepsia and duodenal eosinophilia, who've had little to no relief from acid-reduction therapy and montelukast. They must have had a previous endoscopy showing specific levels of eosinophils. Kids can't join if they're on certain medications like opioids or have liver disease, diabetes, cancer, heart problems, respiratory or kidney diseases.Check my eligibility

What is being tested?

The study tests Ketotifen's effectiveness in treating indigestion linked to duodenal eosinophilia in kids who haven't improved with standard treatments. It compares Ketotifen against a placebo to see if it can replace more expensive therapies earlier in the treatment process.See study design

What are the potential side effects?

Ketotifen may cause side effects such as drowsiness, dry mouth, and mild gastrointestinal issues. Since it's being compared to a placebo which has no active ingredients, any additional side effects observed could be attributed to Ketotifen.

Ketotifen Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had little to no improvement from acid-reduction or montelukast treatments.

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I am between 8 and 17 years old.

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I have had stomach pain for at least 8 weeks that fits the symptoms of functional dyspepsia.

Ketotifen Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, day 28, day 63, and day 147

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, day 28, day 63, and day 147

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 28, day 63, and day 147 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood pressure

Complete Physical

Heart Rate

+4 more

Secondary outcome measures

Pharmacokinetic Sampling (Area under the plasma concentration versus time curve - AUC)

Pharmacokinetics Sampling (Peak Plasma Concentration - Cmax)

Ketotifen Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: cross-over of KetotifenActive Control1 Intervention

Patients will begin the active ketotifen treatment first and cross over to placebo.

Group II: cross-over of PlaceboPlacebo Group1 Intervention

Patients will begin the placebo treatment first and cross over to the active ketotifen.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,746 Total Patients Enrolled

Craig A Friesen, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City

2 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Ketotifen (Mast Cell Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT02484248 — Phase 3

Indigestion Research Study Groups: cross-over of Ketotifen, cross-over of Placebo

Indigestion Clinical Trial 2023: Ketotifen Highlights & Side Effects. Trial Name: NCT02484248 — Phase 3

Ketotifen (Mast Cell Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02484248 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

How many total individuals are included in this research project?

"Yes, the information on clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

European Journal of Clinical PharmacologyJournal

Ketotifen Pharmacokinetics in Children with Atopic Perennial Asthma

McFadyen, M. L., R. Miller, and T. M. Ludden. 1997. “Ketotifen Pharmacokinetics in Children with Atopic Perennial Asthma”. European Journal of Clinical Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s002280050305.

GutJournal

The Mast Cell Stabiliser Ketotifen Decreases Visceral Hypersensitivity and Improves Intestinal Symptoms in Patients with Irritable Bowel Syndrome

Klooker, T. K., B. Braak, K. E. Koopman, O. Welting, M. M. Wouters, S. van der Heide, M. Schemann, S. C. Bischoff, R. M. van den Wijngaard, and G. E. Boeckxstaens. 2010. “The Mast Cell Stabiliser Ketotifen Decreases Visceral Hypersensitivity and Improves Intestinal Symptoms in Patients with Irritable Bowel Syndrome”. Gut. BMJ. doi:10.1136/gut.2010.213108.

Journal of Pediatric Gastroenterology & NutritionJournal

Symptoms and Subtypes in Pediatric Functional Dyspepsia: Relation to Mucosal Inflammation and Psychological Functioning

Schurman, Jennifer V, Meenal Singh, Vivekanand Singh, Nancy Neilan, and Craig A Friesen. 2010. “Symptoms and Subtypes in Pediatric Functional Dyspepsia: Relation to Mucosal Inflammation and Psychological Functioning”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0b013e3181d1363c.

Clinical Gastroenterology and HepatologyJournal