Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.
- Conditions
- Chronic pancreatitis and primary sclerosing cholangitisMedDRA version: 15.0Level: PTClassification code 10033649Term: Pancreatitis chronicSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 15.0Level: PTClassification code 10008609Term: Cholangitis sclerosingSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-004170-26-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method