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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Huaxiang Wu
- 전화번호: 0571-87783777
- 이메일: wuhx8855@zju.edu.cn
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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;
- 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;
- Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies;
- Pregnant or lactating women;
- Allergy or hypersensitivity to the study drug(s).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Proton Pump Inhibitor (PPI) group
|
Omeprazole cap 20 mg, q.d.
|
|
실험적: Mucosal protectant group
|
Teprenone 50 mg, t.i.d.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12
기간: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of patients with a positive fecal occult blood test
기간: At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
|
changes in levels of hemoglobin
기간: At weeks 4, 8, and 12.
|
At weeks 4, 8, and 12.
|
|
Changes in levels of fecal calprotectin
기간: At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of days covered by medication
기간: 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
|
From enrollment to the end of treatment at 12 weeks
|
|
Incidence of adverse events and serious adverse events.
기간: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-0322
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Omeprazole에 대한 임상 시험
-
Tehran University of Medical Sciences완전한