Clinical Studies with Phospholipid-Associated NSAIDs

描述（改编自应用程序） 拟议临床试验的主要目的是评价 阿司匹林制剂的胃十二指肠毒性和生物活性 (ASA)和另一种非甾体抗炎药（NSAID），双氯芬酸， 化学上与两性离子磷脂，磷脂酰胆碱 （PC）。这将首先通过比较未改性的 阿萨（剂量为650 mg，t.i.d.）ASA-PC测试的结果 在一个月的研究期内，在健康的人类受试者中， 有胃肠道或炎症性疾病史，且不经常 NSAID使用者。受试者最初将接受阿萨或ASA-PC 基于随机化程序，在不少于6个洗脱期后 周将进入研究的第二组，在那里他们将接受 替代药物内窥镜手术将由 对受试者正在服用哪种试验药物不知情的专业人员， 在研究期开始（基线）和结束（随访）时， 胃十二指肠溃疡/糜烂的数量、大小和位置 在视频内窥镜下评分，将进行表面疏水性活检 （接触角分析）、环氧合酶（考克斯）活性（放射免疫测定/RIA） 并采集血液用于评估血小板聚集性、血栓素 （TXB 2）浓度和红细胞压积。第二项研究将设计在一个类似的 以上述方式，比较胃十二指肠毒性和生物学 双氯芬酸（75 mg b.i.d.）除了这种情况 我们将增加研究的第三组，其中受试者被给予 考克斯-抑制剂塞来昔布，剂量（200 mg b.i.d.）具有等同 对双氯芬酸的疗效。

DESCRIPTION (adapted from the application) The major objective of the proposed clinical trial will be to evaluate the gastroduodenal toxicity and biological activity of a formulation of aspirin (ASA) and another non-steroidal anti-inflammatory drug (NSAID), diclofenac, chemically associated with the zwitterionic phospholipid, phosphatidylcholine (PC). This will be accomplished first, by comparing the effects of unmodified ASA (administered at a dose of 650 mg, t.i.d.) to that of the ASA-PC test compound, over a one month study period, in healthy human subjects with no history of gastrointestinal or inflammatory disease and who are not frequent NSAID users. The subjects will initially receive either the ASA or the ASA-PC based upon a randomized program, and after a washout period of no less than 6 weeks will enter the second arm of the study where they will receive the alternate medication. Endoscopic procedures will be performed by the professional staff, who are blinded to which test-drug the subject is taking, at the beginning (baseline) and end (follow-up) of the study period, at which time the number, size and location of gastroduodenal ulcers/erosions will be scored under video-endoscopy, biopsies will be taken for surface hydrophobicity (contact angle analysis), cyclo-oxygenase (COX) activity (radioimmunoassay/RIA) and blood collected for assessment of platelet aggregability, thromboxane (TXB2) conc. and hematocrit. A second study will be designed in a similar manner to the above, to compare the gastroduodenal toxicity and biological activity of diclofenac (75 mg b.i.d.) with diclofenac-PC, except in this case we will add a third arm of the study in which the subjects are administered the COX- inhibitor, Celecoxib, at a dose (200 mg b.i.d.) having equivalent therapeutic efficacy to diclofenac.