Placebo Controlled, Confirmatory Clinical Investigation in Patients With Gastro-oesophageal Reflux, to Characterise the Acid Neutralisation Activity of a Calcite Chewing Gum, Using Oesophageal Ambulatory pH Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- To measure efficacy of the calcite chewing gum versus unmatched placebo by measurement of the mean percentage of time (%) that the pH of the oesophagus is greater or equal to 4 up to 1 hour post dosing
研究概览
简要总结
This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.
详细描述
The primary objective of this confirmatory clinical investigation is to evaluate the acid neutralisation action of a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. The clinical investigation will also assess the efficacy and safety of the calcite chewing gum.
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
盲法说明
Patients and the staff at the Investigative site, will remain un-masked to treatment administered. Masking of the investigation is not required as the investigation endpoints are objective measurements of oesophageal pH and impedance, patients will be randomised to a treatment order.
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
- •Patient with a primary diagnosis of symptomatic GORD in accordance with the Montreal definition. Patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of mild/moderate intensity. If the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms.
- •Patient that are healthy (with the exception of a diagnosis of GORD) as determined by past medical history and vital signs at screening.
排除标准
- •Patients with a history or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) or hiatus hernia which is greater than 3 cm or a history of conditions that can lead to abnormal oesophageal pH.
- •Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity
- •Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit.
- •Patients who are unwilling to refrain from using proton pump inhibitors (PPIs), H2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to the start of treatment period.
结局指标
主要结局
To measure efficacy of the calcite chewing gum versus unmatched placebo by measurement of the mean percentage of time (%) that the pH of the oesophagus is greater or equal to 4 up to 1 hour post dosing
时间窗: 0 to 1 hour post dose
The mean percentage of time (%) that pH is greater or equal to 4 within the oesophagus during the 0-1 hour post dose monitoring period.
次要结局
- To evaluate the efficacy of the test product versus the unmatched placebo by recording the number of acid reflux events (pH is below pH 4) for up to 2 hours post dose(0 to 2 hours post dose)
- To evaluate the efficacy of the test product versus the unmatched placebo by recording the mean percentage of time (%) that the pH within the oesophagus is raised greater or equal to 4 over the period 1-2 hour post dose(1 to 2 hours post dose)
- To evaluate the efficacy of the test product versus the unmatched placebo by measurement of the time (mins) taken to observe the first non-acidic reflux event (pH greater or equal to 4 throughout event) immediately after the start of dosing(0 to 2 hours post dose)
- To evaluate the efficacy of the test product versus the unmatched placebo by recording the total number of reflux events up to 2 hours post dose(0 to 2 hours post dose)
- To evaluate the efficacy of the test product versus the unmatched placebo by recording the mean percentage of time (%) that the pH within the oesophagus is raised greater or equal to 4 over the period 0-2 hour post dose(0 to 2 hours post dose)