NCT00547469Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation
Dynogen Pharmaceuticals138 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2007年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 360
- 试验地点
- 138
- 主要终点
- Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
研究概览
简要总结
This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female from 18 to 65 years of age, inclusive
- •Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:
- •Improvement with defecation
- •Onset associated with a change in frequency of stool
- •Onset associated with a change in form (appearance) of stool
- •Negative serum and urine pregnancy tests
- •Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization
排除标准
- •Serious underlying diseases, including psychiatric disorders
- •Current history of conditions affecting bowel transit
- •Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
- •Clinically significant abnormal examination findings or laboratory tests
- •Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
- •Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
- •Presence of a medical condition which could interfere with the interpretation of study data
- •Significant use of nicotine or caffeine
结局指标
主要结局
Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
次要结局
- Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit.
- Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation.
研究者
研究点 (138)
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