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Can a daily acid blocker calm reflux in toddlers?

NCT ID NCT00300755

Symptom relief Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether a daily oral dose of pantoprazole, an acid-reducing medicine, eases GERD symptoms in children ages 1 to 5 who have endoscopically confirmed reflux disease. About 60 children join this Phase 3 trial. Parents track symptoms such as vomiting, gagging, food refusal, trouble swallowing, and belly pain for 8 weeks to see how much scores change from the start.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pantoprazole sodium, a proton-pump inhibitor that reduces stomach acid
What this could lead to
If it works, this could give doctors clearer evidence on a once-daily acid-reducing medicine for young children with confirmed GERD.
What could go wrong
The trial is small, with about 60 children, and results in young children may not apply to older kids or adults. Acid-reducing drugs can cause side effects such as diarrhea or headache, and symptoms may not improve for every child.

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

60 people

The number who actually took part.

Start date

May 2006

Finished

Apr 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 year to 5 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: * Ability to undergo endoscopy with required biopsy * Ages 1 through 5 years * Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply. Exclusion Criteria: * History or presence of upper gastrointestinal anatomic or motor disorders * Known current or active cow's milk allergy * Malignancy * Other exclusions apply.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

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

Gastroesophageal reflux

Contacts and locations

Locations

  • Study site

    Mobile, Alabama, 36604, United States

  • Study site

    Phoenix, Arizona, 85016, United States

  • Study site

    Oakland, California, 94609, United States

  • Study site

    Orange, California, 92868, United States

  • Study site

    Sacramento, California, 95819, United States

  • Study site

    San Diego, California, 92103, United States

  • Study site

    Wilmington, Delaware, 19803, United States

  • Study site

    Washington D.C., District of Columbia, 20010, United States

  • Study site

    Gainesville, Florida, 32610, United States

  • Study site

    Jacksonville, Florida, 32207, United States

  • Study site

    Miami, Florida, 33101, United States

  • Study site

    Orlando, Florida, 32806, United States

  • Study site

    Pensacola, Florida, 32504, United States

  • Study site

    Peoria, Illinois, 61603, United States

  • Study site

    Lexington, Kentucky, 40536, United States

  • Study site

    Louisville, Kentucky, 40202, United States

  • Study site

    Boston, Massachusetts, 02114, United States

  • Study site

    Boston, Massachusetts, 02115, United States

  • Study site

    Flint, Michigan, 48503, United States

  • Study site

    Southfield, Michigan, 48075, United States

  • Study site

    Jackson, Mississippi, 39216, United States

  • Study site

    Omaha, Nebraska, 68105, United States

  • Study site

    Las Vegas, Nevada, 89102, United States

  • Study site

    Egg Harbor, New Jersey, 08234, United States

  • Study site

    Morristown, New Jersey, 07962, United States

  • Study site

    Buffalo, New York, 14222, United States

  • Study site

    New York, New York, 10032, United States

  • Study site

    Oklahoma City, Oklahoma, 73104, United States

  • Study site

    Danville, Pennsylvania, 17822-1320, United States

  • Study site

    Philadelphia, Pennsylvania, 19104, United States

  • Study site

    Houston, Texas, 77030, United States

  • Study site

    Temple, Texas, 76508, United States

  • Study site

    Norfolk, Virginia, 23507, United States

  • Study site

    Charleston, West Virginia, 25304, United States

  • Study site

    Huntington, West Virginia, 25701-3655, United States

  • Study site

    Milwaukee, Wisconsin, 53215, United States

  • Study site

    Edmonton, Alberta, T6G 2B7, Canada

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Study site

    Hamilton, Ontario, L8N 3Z5, Canada

  • Study site

    London, Ontario, N6A 4G5, Canada

  • Study site

    Ottawa, Ontario, K1H 8L1, Canada

  • Study site

    Montreal, Quebec, H3H 1P3, Canada

  • Study site

    Montreal, Quebec, H3T 1C5, Canada

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