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.

NCT Number	NCT07654049
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Gastrointestinal and Digestive Disorder
Enrollment	100 participants
Start Date	2026-06-01
Primary Completion	2027-06-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-17