NCT00153153已完成4 期
Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
Braintree Laboratories45 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年8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
- 300
- 试验地点
- 45
- 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
To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients at least 18 years of age
- •Constipated according to ROME I criteria
- •On average, fewer than 3 satisfactory BMs per week during the observation period
- •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
- •Are otherwise in good health, as judged by a physical examination
- •In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
排除标准
- •Patients with heme positive stool at screening. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.
- •Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.
- •Patients with known or suspected perforation or obstruction.
- •History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
- •Patients with a known history of organic cause for their constipation.
- •Patients meeting the ROME definition of Irritable Bowel Syndrome
- •Patients currently taking any of the following medications that are known to effect bowel habits:
- •Antidiarrheals
- •Antacids containing magnesium or aluminum salts
- •Anticholinergics
- •Antispasmodic agents
- •Erythromycin and other macrolides
- •Octreotide
- •Lotronex, Zofran, or other 5-HT3 antagonists
- •Zelnorm, or other 5-HT4 agonists
- •Opiods/narcotic analgesics
- •Prokinetics
- •Serotonin re-uptake inhibitors or tricyclic antidepressants
- •Calcium antagonists
- •Patients who are breastfeeding, pregnant, or intend to become pregnant during the study.
- •Female patients of childbearing potential who refuse a pregnancy test.
- •Patients with a known allergy to corn or polyethylene glycol.
- •Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- •Patients who, within the past 30 days have participated in an investigational clinical study
- •Patients that have undergone a colonoscopy within 30 days of beginning the 14 day observation period.
- •Patients that are currently taking, or have previously been treated with polyethyleneglycol3350
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 events and laboratory testing)
研究者
研究点 (45)
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