Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Number of small intestinal mucosal lesions under capsule endoscopy
研究概览
简要总结
All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa.
详细描述
In this prospective randomized controlled study, 100 patients with NSAIDS-related intestinal mucosal injury will be enrolled in 10 clinical centers across China from July 2021 to December 2022. All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa. Laboratory tests including blood routine, stool routine, and occult blood were performed at the beginning and end of the study. Abdominal symptoms and signs were assessed by two experienced clinicians at week 0, 1, 2, and 4 (8) of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 4 weeks before the study, NSAIDs were taken at least once a day with symptoms and signs of abdominal discomfort, such as abdominal pain, abdominal distension and dyspepsia;
- •During the 8-week observation period of the study, NSAIDs will continue to be used in the same protocol (whether to stop NSAIDs during the study remains to be determined);
- •Patients taking antisecretory drugs such as proton pump inhibitors or H2 receptor antagonists and gastric mucosal protectors such as rebapide or tiprexone were eligible;
- •Willing to sign informed consent
排除标准
- •Active gastrointestinal bleeding;
- •Taking more than two NSAIDs, anticoagulants, steroid hormones or prostaglandin derivatives;
- •Have a history of gastrointestinal surgery except appendectomy;
- •Suspected small bowel obstruction;
- •gastroduodenal ulcer;
- •Severe cardiopulmonary diseases (NYHA grade IV cardiac function or respiratory failure);
- •Significant renal impairment (serum creatinine ≥2 mg/dL or glomerular filtration rate GFR<40 mL/min);
- •Liver insufficiency (liver function: total bilirubin >ULN, ASpartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN);
- •Confirmed or suspected combined with malignant tumor;
- •pregnant and lactation women or women who do not exclude the possibility of pregnancy;
- •Drug addicts or alcoholics;
- •Participants in other drug trials within 3 months;
- •The researcher considers it unsuitable for participants
研究组 & 干预措施
Irsogladine Maleate
干预措施: Irsogladine Maleate (Drug)
Hydrotalcite
干预措施: Hydrotalcite (Drug)
结局指标
主要结局
Number of small intestinal mucosal lesions under capsule endoscopy
时间窗: 8 weeks
After 8 weeks of treatment, capsule endoscopy was repeated, and the number of small intestinal mucosal lesions under the microscope decreased by ≥1 or the Lewis score decreased by more than before, which was considered effective.
次要结局
未报告次要终点