NCT00319670已完成4 期
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Braintree Laboratories2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年3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
- 25
- 试验地点
- 2
- 主要终点
- Efficacy will be measured by analysis of patient self-reported BM data.
研究概览
简要总结
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
详细描述
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female constipated outpatients between the ages of 4 and 16
- •Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks
- •Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
- •Are otherwise in good health, as judged by a physical examination
- •If female and of childbearing potential, patient must be 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
- •In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent
排除标准
- •Patients with heme positive stool at baseline exam
- •Patients who are impacted at baseline exam
- •Patients that are not receiving PEG 3350
- •Patients on PEG 3350 that continue to have problems
- •Patients with known or suspected perforation or obstruction
- •Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
- •Patients with a known history of organic cause for their constipation.
- •Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics.
- •Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
- •Female patients of childbearing potential who refuse a pregnancy test
- •Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
- •Patients with known allergy to PEG or PEG containing medications
- •Patients who, within the past 30 days have participated in an investigational clinical study
结局指标
主要结局
Efficacy will be measured by analysis of patient self-reported BM data.
Adverse events will be monitored and analyzed for safety purposes.
次要结局
- Patient acceptance will be measured by analysis of subjective questionnaire data.
研究者
研究点 (2)
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