EUCTR2012-004170-26-IT
Active, not recruiting
Not Applicable
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 sites200 target enrollmentOctober 11, 2012
ConditionsChronic 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic pancreatitis and primary sclerosing cholangitis
- Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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