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New drug aims to stop nighttime heartburn in its tracks

NCT ID NCT07268820

Symptom relief Sponsor: Incheon St.Mary's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a newer drug, zastaprazan, can relieve nighttime heartburn better than the standard drug esomeprazole in people with erosive GERD. About 160 Korean adults with nighttime heartburn for over 3 months will take one of the two drugs and report their sleep quality. The goal is to see if zastaprazan helps more people sleep without heartburn-related disturbances.

What this could mean

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

Active substance
Zastaprazan (a P-CAB drug) and esomeprazole (a PPI drug)
What this could lead to
If zastaprazan works better, it could offer a new option for people with GERD who struggle with nighttime heartburn and sleep problems.
What could go wrong
This is a small, early-phase trial in one country, so results may not apply to everyone. It compares two similar drugs, so the difference may be small or none.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

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

Started

Jul 2025

Expected to finish

Sep 2026

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

19 years and older

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. Korean adults aged 19 years or older as of the date of written consent 2. Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD) 3. Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1) 4. Those who voluntarily decided to participate and provide written informed consent Exclusion Criteria: 1. Those who cannot undergo upper gastrointestinal endoscopy (EGD) 2. Individuals with a history of drug or alcohol abuse (within the past year) 3. Individuals who have received other investigational products within one month prior to the screening visit (Visit 1) 4. In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study

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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.

GERD

How to take part

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

  1. The places running it

    10 sites. 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

  • Catholic University of Korea, Incheon ST. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Hallym University Chuncheon Sacred Heart Hospital

    RECRUITING

    Chuncheon, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, South Korea

  • Kyung Hee University Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Chilgok, South Korea

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, South Korea

  • Soonchunhyang University Hospital

    RECRUITING

    Seoul, South Korea

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