NCT04949828已完成不适用
Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)
AbbVie6 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年9月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire
研究概览
简要总结
Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Medical history of chronic pancreatitis (CP).
- •Diagnosis of Exocrine Pancreatic Insufficiency (EPI).
排除标准
- •-History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
研究组 & 干预措施
Participants on CREON
干预措施: CREON (Drug)
结局指标
主要结局
Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire
时间窗: Up to 1 month
次要结局
- Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue(Up to 1 month)
研究者
研究点 (6)
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