A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Revaprazan tablets in comparison with Omeprazole capsules in patients suffering from Peptic Ulcer or Acute Gastritis

Cadila Healthcare Ltd6 个研究点分布在 1 个国家目标入组 200 人开始时间: 2010年6月16日最近更新: 2018年11月13日

试验速览

阶段: 3 期
状态: 已完成
发起方: Cadila Healthcare Ltd
入组人数: 200
试验地点: 6
主要终点: The endoscopic improvement rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an open label, comparative, multicentric study comparing the safety and efficacy of Revaprazan 200 mg tablets and Omeprazole 20 mg capsules given once daily each for 4 weeks; in 200 patients with Peptic Ulcer or Acute Gastritis that will be conducted in India. The primary outcome measures will be the endoscopic improvement rate and symptomatological improvement rate at the end of study..

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 19.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•1.Patients of either sex of 19 to 75 years of age.
•2.Established diagnosis of peptic ulcer or acute gastritis.
•3.Informed consent of the patient/relative.

排除标准

•1.Pregnancy or Lactation.2.Clinically significant disorder of liver, kidney, cardiovascular system, respiratory system, endocrine system and CNS.3.Not eligible to undergo endoscopy.4.Zollinger-Ellison syndrome.5.Patients requiring use of any unacceptable concomitant medications6.Patients with any other serious concurrent illness or malignancy.7.Patients with continuing history of alcohol and / or drug abuse.8.Participation in another clinical trial in the past 3 months.

结局指标

主要结局

The endoscopic improvement rate

时间窗: Baseline & 4 Weeks

次要结局

Improvement in total score of GI symptoms(0, 1, 2, 3 & 4 weeks)

研究者

发起方

Cadila Healthcare Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (6)

Loading locations...

相似试验

已完成

3 期

Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) InfectionHIV Infections

NCT02733419Hoffmann-La Roche84

已完成

3 期

Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant RecipientsRenal Transplantation

NCT02686619Hoffmann-La Roche237

已完成

3 期

A Clinical study to compare the effictiveness and safety of Forb 100 HFA aerosol for inhalation and Foradil Combi set of capsules with inhalation powder in patients with Asthma.

CTRI/2017/05/008531RUS Biopharm LLC140

招募中

3 期

A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast CancerBreast Cancer

NCT06954961InventisBio Co., Ltd640

已完成

4 期

A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual ComponentsPrimary Hypertension

NCT00819104AstraZeneca402