A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
研究概览
简要总结
This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: 18-30 kg/m^2
- •Body Weight 60-80 kg
- •Participant with both a normal stomach and proximal duodenum mucosa as evidenced by endoscopic results
排除标准
- •Participant with evidence of current/active, or a history of gastrointestinal disease
- •Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy
- •Participant with a history of using antacids, H2 receptor antagonists, proton pump inhibitors, or misoprostol more than twice a month or has used any of these medications within 1 week of Visit
- •Participant with a current or recurrent disease, within 12 months of Visit 1, that could affect the action, absorption, disposition, or excretion of the study treatments or evaluation of the clinical or laboratory tests
研究组 & 干预措施
Ibuprofen Capsule
Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water
干预措施: Ibuprofen (Drug)
Paracetamol Tablet
Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water.
干预措施: Paracetamol (Drug)
Ibuprofen Tablet
Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water
干预措施: Ibuprofen (Drug)
Placebo Tablet
Placebo tablets, 2 tablets QID administered with water.
干预措施: Placebo (Other)
结局指标
主要结局
Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
时间窗: Day 7
Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
次要结局
- Incidence of Gastric and/or Duodenal Mucosal Injury(Day 7)
- GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet(Day 7)
- Duodenal Mucosal Damage (DMD) Scores(Day 7)
- Incidence of Fecal Occult Blood(Day 7)