Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Pancreatectomy and Other Conditions Except Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 579
- 试验地点
- 189
- 主要终点
- Number of Patients With Adverse Drug Reaction
研究概览
简要总结
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.
详细描述
Criteria for evaluation:
- Adverse events
- Nutritional endpoints
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
- Symptoms related to exocrine pancreatic insufficiency
- Steatorrhoea
- Frequency of bowel movements
- Diarrhoea
- Foul stool odour
- Decreased appetite
- Abdominal distension
- Patient's quality of life (QOL)
- Degree of general improvement
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
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lipacreon
In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.
Also, the dose was adjusted appropriately according to the patient's condition.
干预措施: Lipacreon (Drug)
结局指标
主要结局
Number of Patients With Adverse Drug Reaction
时间窗: At week 52
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved. 2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
次要结局
- Patient's Quality of Life - Physical Health (Summary)(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Nutrition Endpoints - Total Cholesterol(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Degree of General Improvement(At week 52)
- Nutritional Endpoints - Serum Total Protein(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - General Health(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Physical Functioning(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Nutritional Endpoints - BMI(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Nutrition Endpoints - Albumin(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Nutrition Endpoints - Triglycerides(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Nutrition Endpoints - Haemoglobin(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Role Physical(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Body Pain(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Mental Health (Summary)(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Vitality(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Social Functioning(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Mental Health(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Patient's Quality of Life - Role Emotional(Baseline, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)
- Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension(Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks)