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Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-06-01
Completion Date
2027-06-01
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Omeprazole
Omeprazole cap 20 mg, q.d.
Teprenone
Teprenone 50 mg, t.i.d.