NCT00630370终止2 期
A Phase II, Randomized, Adaptive Design, Multicenter, Parallel Group, Placebo-Controlled, 58 Day, Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
研究概览
简要总结
To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.
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
- 否
入选标准
- •Were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening.
- •Experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening.
- •Had a normal upper GI endoscopy within the past year.
排除标准
- •Heartburn that occurs >3 times per week
- •Current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening
- •Any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening
- •At screening, a QT interval corrected for heart rate using Bazett's correction formula (QTcB) >440 msec as determined by the Investigator.
研究组 & 干预措施
1
Placebo Comparator
2 Placebo tablets, TID, orally, 58 days
干预措施: Placebo (Drug)
2
Experimental
1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
干预措施: 20 mg ATI 7505 (Drug)
3
Experimental
1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
干预措施: 40 mg ATI 7505 (Drug)
4
Experimental
2 ATI 40mg tablets, TID, orally, 58 days
干预措施: 80 mg ATI 7505 (Drug)
结局指标
主要结局
Efficacy of 3 oral dosing regimens of ATI 7505 vs. placebo in patients with PDS.
时间窗: Day 42
次要结局
- Safety and tolerability of ATI 7505(42 days)
- Time to recurrence of the 2 primary PDS symptoms at day 42(42 days)
- Effect of ATI 7505 treatment on quality of life indices(42 days)
研究者
研究点 (1)
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