Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点目标入组 200 人开始时间: 2012年10月11日最近更新: 2014年6月2日

适应症

试验速览

暂无简介。

•1 – male or female between 18 and 75 years at screening
•2 – diagnosis of chronic pancreatitis or primary sclerosing cholangitis for at least 1 year
•3 – written informed consent
•4 – awareness of the protocol and willingness to adhere to protocol requests
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Exclusion criteria
•1 – acute pancreatitis at enrollement or needing of surgery
•2 – acute cholangitis at enrollment or needing of surgery
•3 – primary biliary cirrhosis
•4 - Hyperthyroidism
•5 – pregnancy and brestfeeding
•6 – hypersensibility to fluimucil or its components
•7 – peptic ulcers
•8 – arterial hypertension
•9 – laboratory findings at screening considered significantly abnormal from the physician
•10 – withdraw of informed consent

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI