CTRI/2010/091/002965未知3 期
?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. Ltd4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The primary efficacy parameter is the evaluation of GERD symptom score on day 14 & day 28.
研究概览
简要总结
This study is 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 that will be conducted in four centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary efficacy parameter is the evaluation of GERD symptom score on day 14 & day 28.
时间窗: on Day 14 and Day 28
次要结局
- oIndividual mean frequency of each GERD symptom [Time Frame: 4 weeks] oIndividual mean score for respiratory symptoms [ Time Frame: 4 weeks ] oChange in endoscopy results at end of study in patients with a second endoscopy(4 weeks)
研究者
研究点 (4)
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