A RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED, COMPARATIVE, PARALLEL GROUP, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF DEXLANSOPRAZOLE VERSUS LANSOPRAZOLE FOR GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Cipla Ltd0 个研究点目标入组 242 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Note: There is no upper age limit
•Screening Visit 1
•1.Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any study related procedures.
•2.Patients of both the sexes of age 18 years and above, who can read and write.
•3.The patients with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 2 months prior to screening.
•Screening Visit 2 and Baseline Visit
•1.The patients who experience heartburn on at least 4 of the 7 days of the screening period.

•Screening Visit 1:
•1.Patient chronically using non steroidal anti inflammatory drugs including COX-2 inhibitors (greater than 12 doses per month) other than aspirin (less than or equal to 325 mg is allowed) within last 14 days.
•2.Need for continuous anticoagulant therapy
•3.History of hypersensitivity to study drugs or any of its components
•4.Severe unstable or uncontrolled disease
•5.History of alcohol or drug abuse or dependence
•6.Participation in an investigational study within 30 days prior to screening
•7.Female who is pregnant or lactating or planning to become pregnant.
•8.Woman of child bearing potential who is unwilling to use adequate methods of contraception.
•Screening Visit 2 and Baseline Visit
•1.Patient with GERD complications like Endoscopic Barretts oesophagus and/or definite dysplastic changes in the oesophagus
•2.Patient with Zollinger-Ellision syndrome or other hypersecretory condition
•3.Patient with pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
•4.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.
•5.Clinically significant laboratory values, as judged by the investigator (as per the assessment on screening visit 2 / Baseline visit)

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