Omeprazole
DrugOmeprazole cap 20 mg, q.d.
NCT Number: NCT07654049
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Omeprazole cap 20 mg, q.d.
Teprenone 50 mg, t.i.d.
Time frame: From enrollment to the end of treatment at 12 weeks
Time frame: At weeks 4, 8, and 12
Time frame: At weeks 4, 8, and 12.
Time frame: At weeks 4, 8, and 12
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
Time frame: From enrollment to the end of treatment at 12 weeks
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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.
NCT07222943
Abdominal Pain, Abdominal Pain/ Discomfort
Austin, Texas, United States
View Trial DetailsNCT03022955
Digestive System Diseases, Gastrointestinal and Digestive Disorder
Basel, Switzerland
View Trial DetailsNCT07716670
Artificial Intelligence (AI) in Diagnosis, Biliary Disease
View Trial DetailsNCT07678645
Atopic Dermatitis (AD), Bile Duct Diseases
Shanghai, Shanghai Municipality, China
View Trial Details