NCT01716052终止不适用
Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
Kenneth A. Kist,1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Measure of Discomfort of Mammography
研究概览
简要总结
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.
详细描述
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must have signed the informed consent.
- •Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain
排除标准
- •May not have taken ibuprofen or other pain medication within the last 12 hours.
- •Must not have a contraindication for taking ibuprofen e.g:
- •No history of allergic reactions to ibuprofen or aspirin
- •No recent history with the last year of bleeding from GI tract
- •Not pregnant or suspected of being pregnant
研究组 & 干预措施
Ibuprofen
Active Comparator
Pfizer 200 mg caplets (Advil)
干预措施: Ibuprofen (Drug)
Placebo
Placebo Comparator
Lactulose
干预措施: placebo (Drug)
结局指标
主要结局
Measure of Discomfort of Mammography
时间窗: 3 years
The primary outcome measure will be the response to questions on a questionnaire.
次要结局
未报告次要终点
研究者
Kenneth A. Kist,
Principal Investigator
The University of Texas Health Science Center at San Antonio
研究点 (1)
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