?A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of the fixed-dose combination of Rabeprazole Sodium 20 mg and Levosulpiride SR 75 mg oral capsules versus Rabeprazole Sodium 20 mg oral tablet in patients with Gastroesophageal Reflux Disease?

M/s. Acme Formulation Pvt. Ltd0 个研究点目标入组 200 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。

•All subjects with duly filled and signed in ICFs [Informed Consent Forms]
•Adult males or females, age 18-65 years (inclusive).
•Gastroesophageal Reflux Disease with endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis.
•Sexually active female patients of childbearing potential must practice adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must by negative. Female patients must not be breast-feeding.

•Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
•History or presence of upper gastrointestinal anatomic or motor disorders.
•Acute peptic ulcer and/or ulcer complications
•History of hematemesis within last 3 months of therapy.
•Known current or active cow` s milk allergy
•Any major hematologic, hepatic, metabolic, gastrointestinal or endocrine disorder requiring any other anti-GERD medication
•Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
•History of a myocardial infarction within 30 days of potential study enrollment.
•History of hypersensitivity and/or idiosyncratic reaction to benzimidazoles.
•History of drug or medication abuse within the past year, or current alcohol abuse.
•Previous participation in this or any other Rabeprazole Sodium 20 mg clinical trial.
•Terminally ill or moribund condition with little chance of short term survival.
•Serum creatinine >3.5 mg/dL
•Concomitant diseases such as malignancy, HIV.

发起方

M/s. Acme Formulation Pvt. Ltd