NCT01012908Unknown2 期
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Amount of fat in the stools of 72 hours of medication use between the two treatments.
研究概览
简要总结
The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.
详细描述
As a secondary objective will be assessed the following parameters:
- Incidence of abdominal pain;
- Frequency of flatus;
- Frequency of bowel movements during the treatment;
- Consistency of stools during treatment;
- Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
- •Be aged over 18 years;
- •Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
- •Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
- •Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
- •Present ability to meet the patient's diary;
- •Be clinically compensated with replacement therapy;
- •Must be admitted patients in both the sexes;
- •Must be accepted patients of any ethnicity.
排除标准
- •Cystic fibrosis;
- •Acute pancreatitis;
- •Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
- •Diabetes decompensated;
- •Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
- •Any type of treatment for morbid obesity;
- •Abusive use of alcohol in the three months preceding the study;
- •Pregnancy and lactation.
研究组 & 干预措施
Norzyme
Experimental
Pancreatic Enzymes - Norzyme (Bergamo)
干预措施: Norzyme - Bergamo (Dietary Supplement)
Creon (Solvay)
Active Comparator
Pancreatic Enzymes - Creon (Solvay)
干预措施: Creon (Dietary Supplement)
结局指标
主要结局
Amount of fat in the stools of 72 hours of medication use between the two treatments.
时间窗: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
次要结局
- Frequency of bowel movements per day(First period: days 1 - 14. Second period: days 1-14. (every day))
- Consistency and characteristics of feces(First period: days 1 - 14. Second period: days 1-14. (every day))
- Frequency and intensity of abdominal pain daily(First period: days 1 - 14. Second period: days 1-14. (every day))
- Frequency of flatulence daily(First period: days 1 - 14. Second period: days 1-14. (every day))
- Amount of drug used in treatment(First period: days 1 - 14. Second period: days 1-14. (every day))
研究者
研究点 (1)
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