NCT00441519已完成1 期
An Open-Label, Investigator-Blinded, Stratified, Randomized, Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
POZEN4 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The primary endpoint is the occurrence of gastric and/or duodenal bulb lesions meeting Grade 3 or Grade 4 Lanza (1988) scores for the stomach and duodenal bulb (combined).
研究概览
简要总结
To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
详细描述
Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 81 mg enteric coated (EC) aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.
Secondary: To evaluate the safety and gastrointestinal tolerability, including ulcerogenic potential, and the effect on gastric pH of PA 325.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of:
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- •Childbearing potential has a negative pregnancy test at screening, and at least one of the following applies or is agreed to by the subject:
- •Complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study and for 30 days after completion of the study
- •Female sterilization or sterilization of male partner; or,
- •Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
- •Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
- •Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
- •Any other method with published data showing that the lowest expected failure rate is less than 1% per year
- •Subject is > 50 years of age inclusive at the time of dosing
- •Subject does not currently smoke and has not smoked for at least 3 months
- •The subject's physical status is within normal limits of age and consistent with observations at screening
- •The subject's Body Mass Index (BMI) is between 20-30 kg/m2
- •Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed
排除标准
- •History of hypersensitivity to omeprazole or to another proton-pump inhibitor
- •History of allergic reaction or intolerance to aspirin or any NSAID and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- •Participation in any study of an investigational treatment in the 4 weeks before Day 1 dosing
- •Presence of uncontrolled acute or chronic medical illness, e.g. GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
- •GI disorder or surgery leading to impaired drug absorption
- •Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion, would endanger a subject if he or she were to participate in the study
- •Schizophrenia or bipolar disorder
- •Use of any concomitant medication not approved by the study physician during the washout period and during the study conduct
- •Serious blood coagulation disorder, including use of systemic anticoagulants
- •Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to dosing
- •Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1,500 mL of blood in 180 days; 2,500 mL of blood in 1 year
- •Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)
- •Gastric pH > 3 at Day - 1 endoscopy
- •Screening laboratory alanine transaminase (ALT) or aspartate transaminase (AST) value > 2 times the upper limit of normal
- •Estimated creatinine clearance < 30 ml/min at screening
- •Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if he or she were to participate in the study
- •History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infections, or demonstration of HIV antibodies
- •History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
- •Subjects who have previously been a screen failure in this study
- •Subject has excessive alcohol use (>2 units per day on average; for example 2 bottles of beer, two glasses of wine, 2 ounces of liquor/spirits), or recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence
- •Subject has ingested grapefruit or grapefruit juice within 10 days of dosing or will ingest grapefruit or grapefruit juice during the duration of the study
- •Positive illicit drug screen
结局指标
主要结局
The primary endpoint is the occurrence of gastric and/or duodenal bulb lesions meeting Grade 3 or Grade 4 Lanza (1988) scores for the stomach and duodenal bulb (combined).
次要结局
- Secondary endpoints include the incidence of gastric and/or duodenal ulcers, total number of gastric and/or duodenal erosions, gastric pH and any other GI tolerability issues.
研究者
研究点 (4)
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