CTRI/2022/01/039744尚未招募4 期
A prospective, randomized, double-blind, two-arm,active-controlled, parallel, multicentre, post marketingclinical trial to assess the efficacy and safety ofRabeprazole Sodium EC Capsules 20mg as comparedto conventional Rabeprazole Gastro Resistant Tablets IP20mg in patients with gastro-oesophageal reflux disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Male and Female patients of age 18-60 years (both inclusive).
- •2. Patients with established diagnosis of GERD with symptoms of heart burn
- •3. Patients having moderate to severe heart burn symptoms on at least two occasions during the last 7 days
- •4. Patients should not have taken any PPI / H2 receptor blocker in last one week.
- •5. Patients willing to give written informed consent and comply with the study procedure
- •6. Patient literate enough to fill the diary card
排除标准
- •1. Patient is a refractory case of GERD i.e. patient has tried Rabeprazole 20mg /
- •Pantoprazole 40mg or equivalent for 4 weeks without any response in past
- •2. Pregnant or Lactating females; or female patients of childbearing potential unwilling to
- •use effective contraception
- •3. Current or past history of:
- •o Increased gastrointestinal motility e.g. in patients with gastrointestinal
- •hemorrhage, mechanical obstruction or perforation
- •o Atrophic gastritis or gastric malignancy or other GI malignancy
- •o Acute peptic ulcer and/or ulcer complications or history of active gastric or
- •duodenal Ulcers within 4 weeks prior screening
- •o Patients with Zollinger-Ellision syndrome or other hypersecretory condition
- •o GERD complications like Endoscopic Barretts oesophagus and/or definite
- •dysplastic changes in the oesophagus
- •o Pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal
- •o Gastroesophageal surgery and planned surgery during the study duration
- •o Bleeding disorder or History of hematemesis within last 2 months
- •4. Subjects with any other clinically significant uncontrolled systemic diseases such as
- •gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine,
- •immunological or hematological disorders or malignancy
- •5. Subjects with continuing history of alcohol and/or drug abuse
- •6. Subjects with history of allergy to Rabeprazole or any other proton pump inhibitor
- •7. Participation in another clinical trial in the past 3 months prior to screening
- •8. Any other reason for which the investigator feels that patient should not participate
研究者
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