Study Off Efficacy and Rapidity of Action of a Product With Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric Acidity (pH), Symptoms of Gastric Reflux and Hyperacidity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time with intragastric pH > 4 for 20 minutes before and after product intake
研究概览
简要总结
A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.
详细描述
The investigators will include patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake and don't use proton pump blockers or H2-receptor antagonists.
This is a multicentre clinical trial with two-phase design:
Phase I: A double-blind, randomised, placebo-controlled clinical trial to assess the efficacy and rapidity of action of the medical device to reduce clinical symptoms of gastric reflux and hyperacidity under normal conditions of use. This phase I will be performed in primary care clinics.
Phase II: A non-comparative, non-controlled clinical trial to objectively assess, using continuous pH monitoring, the magnitude and rapidity to control gastric and oesophageal pH after taking the product. This phase II will be performed at the Department of Gastroenterology of Medic Center.
The study will begin with the baseline visit (day 0) in which the inclusion and exclusion criteria will be confirmed, the signing of informed consent will be obtained, GERD-Q Questionnaire will be done and treatment will be prescribed, followed by a home recording where patients will record data on episodes of acidity and heartburn occuring during the follow-up week. A face-to-face visit will be at 7 days after to recollect information about total number of daytime and nighttime episodes of acidity/heartburn since the previous visit and repeat the GERD-Q Questionnaire.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes over 18 years of age
- •Patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake
- •Patients not on proton pump blockers or H2-receptor antagonists
- •Patients able to understand the study implications and who sign the informed consent.
排除标准
- •Pregnant or nursing women
- •Patients who are currently using or have used other medications or antacid products for the treatment of reflux and hyperacidity symptoms within 7 days prior to enrolment in this study.
- •Patients treated with antihypertensive drugs, calcium channel blockers or non-steroidal anti-inflammatory drugs (NSAIDs)
- •Patients with hypercalcaemia, hypertension, renal failure or other conditions in which the use of the components of the investigational product is not recommended.
- •Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or prevent their participation in it.
研究组 & 干预措施
Control
The control will consist of a placebo based on excipients without active ingredients that will be formulated so that the tablet has the same appearance as the test product, with three different colour layers.
Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.
干预措施: Control (Other)
Intervention (Antacid)
An Antacid, a CE marked medical device under normal conditions of use.
Sodium alginate (reduces reflux) (250 mg/tablet) Calcium carbonate (reduces acidity) (80 mg/tablet) Magnesium carbonate (reduces acidity) (144 mg/tablet) Hyaluronic acid (mucosal protector) (6.15 mg/tablet) Aloe vera extract without anthraquinones (mucosal protector) (40 mg/tablet)
Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.
干预措施: Antacid (Device)
结局指标
主要结局
Time with intragastric pH > 4 for 20 minutes before and after product intake
时间窗: Baseline visit
Total time in minutes of the time in intragastric pH \> 4 for 20 minutes before and after product intake
Intensity of acidity/heartburn
时间窗: At the beginning and at the end of treatment, an average of 7±1 days in patients
Change in intensity of acidity/heartburn before and after taking the treatment, assessed by the patient using a visual analogue scale (VAS from 0=none to 10=maximum imaginable)
Time elapsed between product intake and intragastric pH > 4
时间窗: Baseline visit
Change in minutes of the time elapsed between product intake and intragastric pH \> 4
Time from treatment intake to resolution or maximum decrease in acidity/heartburn
时间窗: At the beginning and at the end of treatment, an average of 7±1 days in patients
Change in time from treatment intake to resolution or maximum decrease in acidity/heartburn as assessed by the patient using a 3-point Likert scale (\<1 minute, 1-5 minutes, \>5 minutes)
次要结局
- Mean intragastric pH(Baseline visit)
- Time of tablet duration in the mouth before complete dissolution(At the beginning and at the end of treatment, an average of 7±1 days in patients)
- Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product(Through study completion, an average of 6 months)
- Number of episodes of GER (intraoesophageal pH < 4)(Baseline visit)
- Time with oesophageal pH < 4(Baseline visit)
- Longest reflux episode (oesophageal pH <4)(Baseline visit)
- Demographic data(Baseline visit)
- Number of daytime and nightime episodes of acidity/heartburn(An average of 7±1 days in patients)
- Intensity of reflux before and after treatment(At the beginning and at the end of treatment, an average of 7±1 days in patients)
- Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score(At the beginning and at the end of treatment, an average of 7±1 days in patients)
- Number of Participants With Adverse Events(From the beginning to the end of treatment, an average of 7±1 days in patients)