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Could a Half-Dose of a common drug prevent a painful complication just as well?

NCT ID NCT07088757

Prevention Sponsor: Changhai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a low dose (50 mg) versus the standard dose (100 mg) of indomethacin given rectally before ERCP to prevent post-procedure pancreatitis. About 1,366 adults undergoing ERCP will be randomly assigned to one of the two doses in a double-blind fashion. The goal is to see if the lower dose works just as well while potentially causing fewer side effects.

What this could mean

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

Active substance
indomethacin (a nonsteroidal anti-inflammatory drug given as a rectal suppository)
What this could lead to
If successful, a lower dose could prevent post-ERCP pancreatitis just as effectively as the standard dose, while reducing side effects like bleeding or kidney problems.
What could go wrong
This is a non-inferiority trial, so the lower dose might prove slightly less effective. The study is also limited to adults in China, so results may not apply everywhere.

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 1,366 people

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

Started

Sep 2025

Expected to finish

Dec 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

18 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: * Adults aged 18 years or older. * Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography Exclusion Criteria: * Standard contraindications to ERCP * Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) * Use of NSAIDs within 7 days prior to ERCP * Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure) * Acute pancreatitis within 3 days before ERCP * Hemodynamic instability * Pregnancy or lactation * Patients who are unwilling or unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

acute pancreatitis

As listed by the trial registrant

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

Post-ercp pancreatitis

How to take part

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

  1. The places running it

    12 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

  • Affiliated Hospital of Jiaxing University

    NOT_YET_RECRUITING

    Zhejiang, China

  • Changhai Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Dongyang People's Hospital

    NOT_YET_RECRUITING

    Zhejiang, China

  • First Affiliated Hospital of Ningbo University

    NOT_YET_RECRUITING

    Zhejiang, China

  • Jinhua Central Hospital

    NOT_YET_RECRUITING

    Zhejiang, China

  • People's Hospital of Quzhou

    NOT_YET_RECRUITING

    Zhejiang, China

  • Ruijin Hospital

    RECRUITING

    Shanghai, China

  • Shanghai General Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Shaoxing People's Hospital

    NOT_YET_RECRUITING

    Zhejiang, China

  • Sir Run Run Shaw Hospital

    RECRUITING

    Zhejiang, China

  • Taizhou Enze Medical Center Group

    RECRUITING

    Zhejiang, China

  • Zhuji People's Hospital of Zhejiang Province

    NOT_YET_RECRUITING

    Zhejiang, China

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