CTRI/2009/091/001053已完成3 期
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ilaprazole 10 mg Tablet Vs Omeprazole 20 mg Tablet in patients with Symptomatic Gastroesophageal Reflux Disease (GERD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, Belching
研究概览
简要总结
This study is a Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ilaprazole 10 mg Tablet Vs Omeprazole 20 mg Tablet (Reference Drug), for 4 weeks in 200 patients with Symptomatic Gastroesophageal Reflux Disease. The study will start on 15th January 2010.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Efficacy will be measured by assessing change from baseline to week 1, 2 and 4 symptom and sign scores of heartburn, acid regurgitation, epigastric pain/ bloating, and belching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and non-pregnant females (with negative β-human chorionic gonadotrpin test).
- •Female patients on adequate contraceptive control.
- •Patients with diagnosis of symptomatic GERD, ie.
- •History of atleast 2 episodes of heartburn per week that partially responded to treatment with a proton-pump inhibitor (PPI),
- •Patient willing to comply with study procedures and requirements.
排除标准
- •Pregnant and nursing women.
- •History of previous esophageal or gastric surgery.
- •History of bleeding tendencies, cirrhosis and esophageal varices.
- •History of hypersensitivity or allergy to Omeprazole or Ilaprazole.
- •Patients who would require concomitant therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates (>165 mg/day), quinidine, warfarin, diazepam, diphenylhydantoins, mephenytoin, H2-receptor antagonists, anticholinergics or prostaglandin analogues.
- •Alcoholics, smokers, tobacco addicts.
- •Immunocompromised states and patients with systemic infections.
- •Patients with severe cardiac, hepatic, renal, or cerebrovascular diseae, malignancy, chronic uncontrolled systemic disease e.g., diabetes, hypertension, asthma, collagen disorders, etc.
- •or any other serious medical illness.
- •Patients who have participated in a new drug study in the past 3 months.
- •Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
结局指标
主要结局
Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, Belching
时间窗: Day 0, Week 1, Week 2 and Week 4
次要结局
- Safety(Day 0, Week 1, Week 2 and Week 4)
研究者
研究点 (3)
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