NCT00153127已完成4 期
Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
Braintree Laboratories4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2001年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
研究概览
简要总结
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female ambulatory outpatient age 19 or older.
- •Patients meet ROME II Criteria
- •Patients not meeting ROME IBS criteria
- •Use of a constipating medication (>= 3% in PDR)
- •If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
- •Written informed consent.
排除标准
- •Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- •Prior small bowel or colonic resection or colostomy.
- •Weight < 80 lbs.
- •Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
- •Positive stool hemoccult.
- •Significant cardiac, renal or hepatic insufficiency.
- •Pregnant or expecting to become pregnant within 120 days of study enrollment.
- •Lactating or breast feeding.
- •Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
- •Use of investigational drugs in the last 30 days.
- •Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions
结局指标
主要结局
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
次要结局
- Analysis of individual ROME I criteria
- Safety (adverse event and laboratory testing)
研究者
研究点 (4)
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