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Could a common allergy drug soothe Kids' chronic stomach pain?

NCT ID NCT02484248

Symptom relief Sponsor: Craig A. Friesen, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether ketotifen, a drug that stabilizes certain immune cells, can reduce stomach pain in children aged 8-17 with functional dyspepsia and high levels of eosinophils in the gut. Participants will receive both ketotifen and a placebo at different times to compare effects. The goal is to see if ketotifen can be a simpler, cheaper treatment option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2015

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. between the ages of 8 and 17 years, inclusive 2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5); 3. previous endoscopy with biopsies demonstrating \>20 eosinophils/high powered field on duodenal mucosal biopsies; 4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response; 5. evidence of written parental permission (consent) and subject assent; 6. Negative pregnancy screening for females of child bearing potential. Exclusion Criteria: 1. previous treatment with ketotifen; 2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment; 3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care; 4. Pregnant/planning to become pregnant; 5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy; 6. Epilepsy or history of seizures; 7. Liver disease or elevation of liver enzymes; 8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids; 9. Allergy to ketotifen or other products in capsule 10. Refusal of Urine pregnancy test in post-menarchal females.

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Conditions

The condition(s) this trial relates to.

dyspepsia Eosinophilia functional gastric disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional dyspepsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

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