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Could a stomach shield drug replace acid blockers for steroid users?

NCT ID NCT07654049

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 teprenone, a stomach-protecting drug, can reduce gastrointestinal damage caused by high-dose steroids in people with lupus. One hundred participants will be randomly assigned to take either teprenone or the standard acid-blocker omeprazole for 12 weeks. The goal is to see if teprenone works as well or better at easing stomach symptoms and preventing injury.

What this could mean

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

Active substance
Teprenone
What this could lead to
If it works, this could offer a gentler alternative to standard acid-blockers for preventing stomach damage from steroids.
What could go wrong
This is a small, early-stage trial with only 100 participants, so results may not apply to everyone. Teprenone may not be as effective as omeprazole.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

18 to 70 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. Age 18 to 70 years; 2. Patients diagnosed with systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria for SLE; 3. Receiving moderate to high doses of glucocorticoids (prednisone or its equivalent 30-60 mg , once daily); 4. Voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: 1. Presence of other gastric mucosal lesions, such as active ulcers, active bleeding, gastric cancer, gastric polyps, etc.; 2. History of subtotal gastrectomy; 3. History of endoscopic treatments, such as Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR); 4. Significant psychiatric and behavioral abnormalities or mood disorders; 5. History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) \< 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG; 6. Laboratory abnormalities at screening as follows: Total bilirubin \> 3 times ULN (Upper Limit of Normal); AST/ALT \> 3 times ULN; Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m²; 7. Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies; 8. Pregnant or lactating women; 9. Allergy or hypersensitivity to the study drug(s).

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder systemic lupus erythematosus

As listed by the trial registrant

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

Gastrointestinal and digestive disorder

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.