NCT00392080已完成1 期
A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
研究概览
简要总结
CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
- •If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;
排除标准
- •Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
- •Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
研究组 & 干预措施
3
Placebo Comparator
干预措施: placebo (Drug)
1
Experimental
75 mg BID
干预措施: naproxen (Drug)
2
Experimental
干预措施: CJ-023,423 (Drug)
结局指标
主要结局
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
时间窗: 7 days
次要结局
- Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer(Duration of trial)
- Incidence of treatment-emergent, all-causality GI body system adverse events(Duration of trial)
- Severity of Dyspepsia Assessment (SODA)(Duration of trial)
- Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.(Duration of trial)
- Incidence of any gastric ulcer(Duration of trial)
- Incidence of any duodenal ulcer(Duration of trial)
- Incidence of any gastroduodenal erosion or ulcer(Duration of trial)
- Incidence of any gastric erosion or ulcer(Duration of trial)
- Incidence of any duodenal erosion or ulcer(Duration of trial)
- Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)(Duration of trial)
- Number of gastroduodenal ulcers in each subject(Duration of trial)
研究者
研究点 (1)
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