EUCTR2009-018029-57-GB进行中（未招募）不适用
A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Arthritis Non-Inferiority Study of LT-NS001 versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates - Nature Trial
ogical Therapeutics Inc.0 个研究点目标入组 534 人开始时间: 2010年3月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 534
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written Informed consent.
- •Age 45–80 years, inclusive.
- •Osteoarthritis of knee.
- •Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the previous 28 days prior to screening.
- •Baseline (pre-dose) index joint WOMAC pain index =40 mm, after a 14 day NSAID washout and with no analgesia on the entire day prior to, and on the day of the WOMAC questionnaire (until completed).
- •Body mass index =42 kg/m2.
- •Patients of reproductive potential (males and females) agree to use two acceptable methods of birth control during the study. Abstinence is acceptable for patients who sign an additional statement of risk.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical History / Examination:
- •Pregnant or nursing women.
- •History of documented gastrointestinal bleeding, obstruction or perforation.
- •History of a documented symptomatic gastroduodenal ulcer (not including an asymptomatic ulcer detected by endoscopic screening) in the previous 5 years.
- •Baseline upper gastroduodenal endoscopy with ulcer or >2 total erosions.
- •Inflammatory bowel disease, celiac disease/gluten enteropathy, Whipple’s disease, or other malabsorptive disease.
- •Resting supine blood pressure >180 mm Hg systolic or >105 mm Hg diastolic, with no change in anti-hypertensive medication for 28 days prior to Screening if the patient is receiving anti-hypertensive medication.
- •New York Heart Association Class III or IV cardiac function.
- •Recent (6 months) stroke or myocardial infarction.
- •History of cancer except for excised basal cell or squamous cell carcinoma of the skin >3 years ago.
- •Active or recurrent infection.
- •Psychiatric or neurologic disease precluding participation based on inadequate consent or inability to follow study instructions.
- •Any other medical condition that would prohibit study participation in the view of the Principal Investigator.
- •Lack of peripheral venous access.
- •Active alcohol abuse / drug addiction (including cannabis products) in the previous 2 years.
- •Medications:
- •Allergy to naproxen, acetylsalicylic acid or other NSAID drug.
- •Severe naproxen intolerance in the past.
- •No intra-articular injections in the 28 days prior to screening.
- •Use of a second NSAID including aspirin within 14 days prior to baseline endoscopy, or planned use during study participation.
- •Use of an anti-coagulant or anti-platelet drug within 14 days prior to baseline endoscopy or planned use during study participation.
- •Use of proton-pump inhibitors (PPI), type 2 histamine blockers (H2 blocker), antacids, binding agents including bile acid sequestrants, pancreatic replacement, cholinesterase inhibitors or specified analgesics including narcotics within 14 days prior to baseline endoscopy or planned use during study participation.
- •Treatment with an investigational agent (including device) within 28 days or 5 investigational drug half-lives (whichever is longer) of Screening, current participation in another research study, or participation in more than 3 research studies in the previous 12 months.
- •Screening Laboratory Tests:
- •Positive H. pylori stool antigen test
- •Hgb <11.5 gm/dL (women) or <12.5 gm/dL (men).
- •Calculated GFR (MDRD) <30 mL/min/1.73 m2.
- •AST or ALT >1.5 times upper limit of normal.
- •Positive hepatitis B surface antigen (HBsAg).
- •Positive anti-hepatitis C (HCV) IgG antibody.
- •Positive anti-human immunodeficiency virus (HIV) 1/2 IgG antibody.
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