Prospective, Open label, observational, Multicenter study for evaluation of efficacy and safety of ACIDEEM Plus Tablet vs Pantoprazole 40mg for Reflux disease, regurgitation and heartburn, acidity in Indian adults for decreasing upper gastrointestinal symptoms.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compared the change in Reflux Disease Questionnaire (RDQ) Score for GERD (Heartburn+ regurgitation)
研究概览
简要总结
The study is a prospective, open label, observational, multicenter, study for evaluation of efficacy and safety of ACIDEEM Plus Tablet vs Pantoprazole 40mg for Reflux disease, regurgitation and heartburn, acidity in Indian adults for decreasing upper gastrointestinal symptomsâ€.
Eligible patients both male, female 18 years of age with symptomatic GERD will be enrolled in the study. The decision to prescribe ACIDEEM Plus Tablet or Pantoprazole tablet will be made by the treating physician as per clinical judgement. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. Treatment duration is 02 weeks and patients will be followed-up till the end of study (week 2).
At screening (Day -1 to Day 0) the potential patients will be identified by site team and a written informed consent (for patients aged 18 years and above would be procured before any study related procedures are undertaken.) The assessment as per schedule of assessments would be performed at screening and enrolment for determining the eligibility.
A total of 100 subjects will be enrolled in the study. 50 subjects will receive ACIDEEM Plus tablet twice daily and 50 subject will receive Pantoprazole 40mg tablet as per physician discretion. The subject would be informed to visit clinic at 1 weeks (Visit 2), and 02 weeks (Visit 3). Safety assessment will be done throughout study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years of age.
- •2.Patient with diagnosis of uncomplicated symptomatic GERD.
- •3.Patient/Parent/legal guardian willing to give a written informed consent/parental consent/assent form.
- •4.Able to/Willing to strictly adhere to investigator’s prescription.
排除标准
- •1.Individuals were excluded if they had taken any medications which might interfere with the action of the study medications prior to the start of the study or during the study.
- •2.Patient having a clinical history or symptom profile suggestive of complicated GERD, other GI diseases (including Barrett’s oesophagus, acute peptic ulcer, or indication for Helicobacter pylori eradication therapy) or any severe diseases of other major body systems.
- •3.Patient having any existing conditions that might compromise their safety or participation in the study.
结局指标
主要结局
Compared the change in Reflux Disease Questionnaire (RDQ) Score for GERD (Heartburn+ regurgitation)
时间窗: Upto 2 weeks
次要结局
- Compared the change in RDQ Scores for individual heartburn, regurgitation and acidity.(Upto 2 weeks)