NCT00414908已完成3 期
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 30
- 主要终点
- Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
研究概览
简要总结
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
- •Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
- •Total stool fat > 40 g over 4 days (using Van De Kamer method)
- •Proven chronic pancreatitis
- •Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
排除标准
- •Ileus or acute abdomen
- •Any type of malignancy involving the digestive tract in the last 5 years
- •Presence of pseudo-pancreatic cyst ≥ 4
- •Continued excessive intake of alcohol or drug abuse
- •Known infection with HIV
研究组 & 干预措施
A
Experimental
干预措施: Pancrelipase delayed release capsule (Drug)
B
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
时间窗: End of double-blind period (5-7 days)
The CFA is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).
次要结局
- Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.(End of double-blind period (5-7 days))
- Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.(End of double-blind period (5-7 days))
- Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.(End of double-period (5-7 days))
- Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period(End of double-period (5-7 days))
- Abdominal Pain at the End of the Double-blind Period.(End of double-period (5-7 days))
- Stool Consistency at the End of the Double-blind Period(End of double-period (5-7 days))
- Flatulence at the End of Double-blind Period(End of double-period (5-7 days))
研究者
研究点 (30)
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