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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal and Digestive Disorder
• Intervention / Treatment: Drug: Omeprazole; Drug: Teprenone

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huaxiang Wu; Phone Number: 0571-87783777; Email: wuhx8855@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proton Pump Inhibitor (PPI) group	Drug: Omeprazole; Omeprazole cap 20 mg, q.d.
Experimental: Mucosal protectant group	Drug: Teprenone; Teprenone 50 mg, t.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with a positive fecal occult blood test	At weeks 4, 8, and 12
changes in levels of hemoglobin	At weeks 4, 8, and 12.
Changes in levels of fecal calprotectin	At weeks 4, 8, and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of days covered by medication	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	From enrollment to the end of treatment at 12 weeks
Incidence of adverse events and serious adverse events.		From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; geranylgeranylacetone
• Other Study ID Numbers: 2026-0322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No