NCT00594854终止3 期
6-Month, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study of Gastric Ulcer Incidence With PN400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects at High Risk for Developing NSAID-Associated Ulcers
POZEN1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Gastric Ulcer Confirmed by Endoscopy
研究概览
简要总结
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm).
At least 20% of the subjects enrolled will be age 65 years and older.
详细描述
To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control.
Secondary:
- To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population
- To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population
- To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument
- To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female subjects, 18 years and older with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical condition expected to require daily NSAID therapy for at least 6 months, with a documented history of an ulcer related serious upper gastrointestinal event such as bleeding, perforation or obstruction
- •Female subjects are eligible for participation in the study if they are of:
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
- •Childbearing potential, have a negative pregnancy test at screening, and at least one of the following applies or is agreed to by the subject:
- •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
- •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 esomeprazole or to another proton-pump inhibitor
- •History of allergic reaction or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- •Positive test result for H. pylori at screening
- •Participation in any study of an investigational treatment in the 4 weeks before screening
- •Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
- •Gastrointestinal 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 they were to participate in the study
- •Schizophrenia or bipolar disorder
- •Use of any excluded concomitant medication (see Section 9.2)
- •A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain
- •Serious blood coagulation disorder, including use of systemic anticoagulants
- •Screening endoscopy showing >10 erosions or any gastric or duodenal ulcer at least 3 mm in diameter with depth
- •Screening laboratory ALT or AST value > 2 times the upper limit of normal
- •Estimated creatinine clearance < 50 ml/min
- •Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study
- •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
研究组 & 干预措施
PN400
Experimental
PN 400 (esomeprazole/naproxen) dosed twice daily
干预措施: PN400 (VIMOVO) (Drug)
Diclofenac/Misoprostol
Active Comparator
diclofenac 75mg/misoprostol 200 mcg dosed twice daily
干预措施: Diclofenac/Misoprostol (Drug)
结局指标
主要结局
Number of Participants With Gastric Ulcer Confirmed by Endoscopy
时间窗: 6 months
Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.
次要结局
- Number of Participants With Duodenal Ulcers Confirmed by Endoscopy(6 months)
- Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score(6 months)
研究者
研究点 (1)
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