Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 79
- 主要终点
- Semi-structured discussion guide
研究概览
简要总结
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
详细描述
Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
- •Development of constipation symptoms since starting opioids.
- •Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.
排除标准
- •Receiving opioid regimen for treatment of pain related to cancer.
- •Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
- •History of cancer within 5 years from the time of screening.
- •Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
- •Has irritable bowel syndrome (IBS) or chronic functional constipation.
结局指标
主要结局
Semi-structured discussion guide
时间窗: Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)
Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener.
次要结局
未报告次要终点