A Multi-centred, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Double Action Chewable Tablets or Matching Placebo Tablets
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
研究概览
简要总结
This study is being conducted to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meets the diagnostic criteria for GERD with a GERD history of frequent episodes of GERD-related symptoms during the last 2 months prior to study screening. The patient must also meet the following criteria:
- •The only or main symptom is heartburn (burning feeling back of breast bone) and/or acid reflux. Symptoms persist or have occurred repeatedly for more than 2 months;
- •As assessed by the Investigator at screening by questioning of the patient, the frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is ≥ moderate within 3 weeks before screening
排除标准
- •Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140 g).
- •Patients who have suffered cardiac chest pain within the last year.
- •Patients who have suffered a recent, significant unexplained weight loss of more than 6 kg in the last 6 months.
- •Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
- •Pregnancy or lactating mother.
- •Patients with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's oesophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H. pylori eradication therapy, known gastrointestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
- •Patients who are observed at screening to have a hiatus hernia with a diameter which exceeds 3 cm.
- •Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days prior to screening or throughout the study.
- •Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2 antagonists during the 5 days prior to screening or systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (except for low dose aspirin which can be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or quadruple therapy for eradication of H. pylori during the last 28 days.
- •Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
- •Patients with difficulty in swallowing.
- •Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
- •Patients with severe constipation, or history of intestinal obstruction.
- •In the opinion of the Investigator, patients with damaged heart or kidney function and patients who require a low sodium diet.
研究组 & 干预措施
Sodium Alginate Double Action Chewable Tablets, then Placebo tablets
4 Compound Sodium Alginate Double Action Chewable Tablets administered as a single dose, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Placebo tablets
干预措施: Sodium Alginate Double Action Chewable Tablets (Drug)
Placebo tablets, then Sodium Alginate Double Action Chewable Tablets
Single dose of 4 Placebo tablets, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Compound Sodium Alginate Double Action Chewable Tablets
干预措施: Sodium Alginate Double Action Chewable Tablets (Drug)
Placebo tablets, then Sodium Alginate Double Action Chewable Tablets
Single dose of 4 Placebo tablets, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Compound Sodium Alginate Double Action Chewable Tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
时间窗: 0 to 4 hours post-dose
The primary efficacy endpoint will be the percentage of time during the 4-hour post-dosing period with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
次要结局
- Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5(0 to 4 hours post-dose)
- Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4(0 to 4 hours post-dose)
- Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5(0 to 4 hours post-dose)
- Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes(0 to 4 hours post-dose)
- Percentage of Time During the First Hour Post-dosing With pH Below pH 4(0 to 1 hour post-dose)
- Percentage of Time During the First Hour Post-dosing With pH Below pH 5(0 to 1 hour post-dose)
- Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4(0 to 1 hour post-dose)
- Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5(0 to 1 hour post-dose)
- The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)(0 to 4 hours post-dose)
- The DeMeester Scores During the 4-hour Post-dosing Period(0 to 4 hours post-dose)