临床试验/NCT04949828

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: 2024年3月28日

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

发起方

AbbVie

申办方类型

Industry

责任方

Sponsor

研究点 (6)

Loading locations...

相似试验

已完成

4 期

Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With CreonCystic FibrosisChronic Pancreatitis

NCT05069597AbbVie30

终止

4 期

A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)Exocrine Pancreatic Insufficiency (EPI)

NCT03859869AbbVie1

撤回

4 期

Pancreatic Enzyme Suppletion in Pancreatic CancerAdenocarcinoma of the PancreasNormal Pancreatic Exocrine Function

NCT01401387Foundation for Liver Research

招募中

不适用

Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement TherapyGut MicrobiotaExocrine Pancreatic InsufficiencyImmunologyAcute Pancreatitis

NCT05480241Centro Hospitalar e Universitário de Coimbra, E.P.E.84

招募中

不适用

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's DiseaseCrohn Disease

NCT03915262Hospices Civils de Lyon50