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

ConditionGastrointestinal and Digestive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omeprazole

    Drug

    Omeprazole cap 20 mg, q.d.

  • Teprenone

    Drug

    Teprenone 50 mg, t.i.d.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Proton Pump Inhibitor (PPI) groupActive comparator 1 intervention
Group B: Mucosal protectant groupExperimental treatment 1 intervention

Trial outcomes

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

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
2

Incidence of adverse events and serious adverse events.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: