CTRI/2021/10/037668已完成4 期
ââ?¬Å?An Open Label, Prospective, Non-comparative, Multicentric, Post marketing surveillance (PMS) Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Ranitidine Hydrochloride 150/ 300 mg Tablet (RantacÃ?® 150/ RantacÃ?® 300 /RantacÃ?® OD 300) of J B Chemicals and Pharmaceuticals Ltd in patients with GERD (Gastroesophageal Reflux Disease)ââ?¬?
JB Chemicals Pharmaceuticals Ltd0 个研究点目标入组 2,446 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,446
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
- •Subjects meeting all the following conditions will be included:
- •1.Male or female patients aged between 18 and 70 years (both inclusive).
- •2.Subjects with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 1 month prior to screening.
- •3.Patients who heartburn in at least 4 days out of 7 days of the screening period
- •4.Written, signed and dated informed consent obtained from patients before performing any study related procedures.
- •5.Patients willing to comply with the protocol requirements.
排除标准
- •Subjects with any of the following conditions will be excluded from the study:
- •1.Subjects with known hypersensitivity to any of the components of the formulation.
- •2.Patients chronically using nonsteroidal anti-inflammatory drugs including COX-2 inhibitors (greater than 12 doses per month) other than aspirin
- •3.Need for continuous anticoagulant therapy
- •4.Severe unstable or uncontrolled diseases.
- •5.History of alcohol or drug abuse
- •6.Patient with Zollinger-Ellision syndrome or other hypersecretory condition
- •7.Patient with pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
- •8.A history of or active gastric or duodenal ulcers within 4 weeks prior or had significant acute upper gastrointestinal hemorrhage within 4 weeks of the baseline endoscopy.
- •9.Pregnancy and lactation:
- •Ã¢â?¬Â¢Pregnant or lactating or planning to become pregnant during the study period.
- •Ã¢â?¬Â¢Females who are not ready to use acceptable contraceptive methods during the course of study.
- •10.Trial related conditions:
- •Ã¢â?¬Â¢Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Ã¢â?¬Â¢Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Ã¢â?¬Â¢Suspected inability or unwillingness to comply with the study procedures.
研究者
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