NCT00705978已完成3 期
A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension
Abbott Products11 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 11
- 主要终点
- Change in CFA from baseline to the end of double blind treatment
研究概览
简要总结
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Pancreatin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CFA from baseline to the end of double blind treatment
时间窗: 7 days after baseline
次要结局
- CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI(7 days after baseline, and end of open-label period (1 year of open label treatment))
研究者
研究点 (11)
Loading locations...
相似试验
已完成
4 期
Creon After Pancreatic SurgeryPancreatic InsufficiencyNCT00535756Abbott Products58
已完成
2 期
Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)Functional ConstipationNCT05803161Beijing Hospital of Traditional Chinese Medicine180
已完成
不适用
A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum DisorderAutism Spectrum DisorderNCT02879110Central South University110
已完成
1 期
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's DiseaseHealthy SubjectsCrohns DiseaseNCT05452304AstraZeneca112
已完成
1 期
Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult ParticipantsNCT06775327Incyte Corporation71