A Multicentric, Open label, Non-Comparative Clinical trial to evaluate the Safety andEfficacy of the Fixed-dose combination of Esomeprazole Magnesium 40 mg DR andLevosulpiride 75 mg ER Capsule in patients with Gastroesophageal Reflux Disease.

Torrent Pharmaceuticals Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or female GERD patient with age of 18 years or above (18 years should be completed)
•-Patients who do not respond to PPI alone and need addition of prokinetic agent to current PPI therapy and can be switched to FDC based on investigator discretion. Patient must have taken any of the following PPIs for at least 2 weeks before screening with inadequate response.)
•Lansoprazole 30 mg/day,
•Pantoprazole 40 mg/day,
•Omeprazole 40 mg/day and
•Rabeprazole 20 mg/day.
•-Patient with prolactin and liver function level (AST,ALT, Bilirubin [total, direct, indirect] and Alkaline phosphatase) within normal limits.
•-Patients who are willing to give informed consent.
•-Patients who are willing to adhere to protocol requirements.

•-History of Barrettâ??s esophagus or dysplastic changes esophagus.
•-History of acute peptic ulcer and/or ulcer complications.
•- History of any malignant disease in any system or organ.
•- Patients with a history of gastric hypersecretory condition eg. Zollinger-Ellison
•-Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic,
•gastrointestinal (other than GERD) or endocrine disorder that may impact outcome of
•study based on investigator discretion.
•- Any major surgery in previous 1 month or history of upper GIT surgery
•- History of alcohol or drug abuse
•- Use of any investigational drug and/or device or participation in another clinical study
•within 1 month before screening.
•- Any psychiatric or mental disease compromising the ability to give the consent for
•participation in the study.
•-Hypersensitivity to PPI or levosulpiride
•- Patient with clinical significant laboratory examination. (Refer inclusion criteria for
•Liver function test & Prolactin level)
•- Women with positive urine pregnancy test.
•-Women who are breast-feeding or females of childbearing potential who are not using
•acceptable contraceptive methods.

发起方

Torrent Pharmaceuticals Ltd