Assessment of the Healing Rate of Erosive or Ulcerative Esophagitis After Two and Four Weeks of Treatment With S-Tenatoprazole-Na (STU-Na) 15 mg, 30 mg, 60 mg, 90 mg and Esomeprazole 40 mg. A Multicenter, Randomized, Double-Blind, Parallel Group Study.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- STEBA France
- 入组人数
- 450
- 试验地点
- 17
- 主要终点
- Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment
研究概览
简要总结
STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis. This trial aims to find out the therapeutic dose of STU-Na required for healing patients with erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90 mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients. The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor the study physician will know, which treatment is administered to the patient.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18 to 75 years inclusive
- •Symptomatic ulcerative or erosive esophagitis
- •Presence of heartburn (daytime and/or nighttime).
- •Understanding the study and agreeing to give a written informed consent
- •Able to communicate well with the investigator him(her)self or his/her representatives
- •Able and agreeing to comply with all study requirements
排除标准
- •gastrointestinal bleeding
- •gastric or esophageal surgery
- •Zollinger-Ellison syndrome
- •primary esophageal motility disorders,
- •esophageal stricture,
- •inflammatory bowel disease,
- •upper gastrointestinal malignancy,
- •pancreatitis,
- •malabsorption
- •Barrett's esophagus (> 3 cm)
- •Severe disease/condition such as malignancy
- •Hypersensitivity to PPIs
结局指标
主要结局
Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment
次要结局
- Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.
- Assessment of complete relief of heartburn