Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07654049

Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury

Objective:

To evaluate the efficacy, safety, and adherence of the gastric mucosal protective agent teprenone in the treatment of glucocorticoid-induced drug-related gastrointestinal injury.

Study Design:

This study is a prospective, open-label, randomized controlled trial. The study population consists of patients with systemic lupus erythematosus requiring medium- to high-dose glucocorticoid therapy (30-60 mg/day). Eligible patients are enrolled according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio into two groups: a proton pump inhibitor (PPI) group and a mucosal protective agent group. The PPI group receives omeprazole capsules 20 mg once daily before meals, while the mucosal protective agent group receives teprenone 50 mg three times daily after meals. Both groups are treated for 12 weeks.

Primary Endpoint:

To assess the improvement in the 7-point overall symptom scale from baseline to week 12.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 70 years;
  • Patients diagnosed with systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria for SLE;
  • Receiving moderate to high doses of glucocorticoids (prednisone or its equivalent 30-60 mg , once daily);
  • Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

  • Presence of other gastric mucosal lesions, such as active ulcers, active bleeding, gastric cancer, gastric polyps, etc.;
  • History of subtotal gastrectomy;
  • History of endoscopic treatments, such as Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR);
  • Significant psychiatric and behavioral abnormalities or mood disorders;
  • 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;
  • 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;
  • Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies;
  • Pregnant or lactating women;
  • Allergy or hypersensitivity to the study drug(s).

Treatment and study plan

Omeprazole

Drug

Omeprazole cap 20 mg, q.d.

Teprenone

Drug

Teprenone 50 mg, t.i.d.

Primary outcomes

  1. Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  1. Proportion of patients with a positive fecal occult blood test

    Time frame: At weeks 4, 8, and 12

  2. changes in levels of hemoglobin

    Time frame: At weeks 4, 8, and 12.

  3. Changes in levels of fecal calprotectin

    Time frame: At weeks 4, 8, and 12

Other outcomes

  1. Proportion of days covered by medication

    Time frame: From enrollment to the end of treatment at 12 weeks

    The proportion of days covered is defined as the number of days with drug availability (without double-counting overlapping days) relative to the total number of days in the observation period

  2. Incidence of adverse events and serious adverse events.

    Time frame: From enrollment to the end of treatment at 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Huaxiang Wu

CONTACT

[email protected]

0571-87783777

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.