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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004170-26-IT

Enrollment

200

Registered

2012-10-11

Start date

2012-12-04

Completion date

Unknown

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis and primary sclerosing cholangitis MedDRA version: 15.0 Level: PT Classification code 10033649 Term: Pancreatitis chronic System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0 Level: PT Classification code 10008609 Term: Cholangitis sclerosing System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: FLUIMUCIL*20CPR EFF 600MG Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion 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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: a. Evaluate effect of NAC on quality of life of patients affected by chronic pancreatitis at EORTC-QLQ C30 and PAN28 questionnaire b. Evaluate effect of NAC on quality of life of patients affected by primary sclerosing cholangitis at EORTC-QLQ C30 and BIL21 questionnaire;Secondary Objective: A – evaluate effect of NAC on pancreatic function measured by blood, fecal , sweet, breath markers and correlate them to clinical outcome B – evaluate effect of NAC on hepatic cholestasis and necrosis evaluated by serum analisis and correlate them to clinical outcome C – evaluate effect of NAC in mucus composition, ROS production by lynphocytes;Primary end point(s): a. Evaluate effect of NAC on quality of life of patients affected by chronic pancreatitis at EORTC-QLQ C30 and PAN28 questionnaire b. Evaluate effect of NAC on quality of life of patients affected by primary sclerosing cholangitis at EORTC-QLQ C30 and BIL21 questionnaire;Timepoint(s) of evaluation of this end point: week 0/4/12/16	—

Measure

Time frame

Main Objective: a. Evaluate effect of NAC on quality of life of patients affected by chronic pancreatitis at EORTC-QLQ C30 and PAN28 questionnaire b. Evaluate effect of NAC on quality of life of patients affected by primary sclerosing cholangitis at EORTC-QLQ C30 and BIL21 questionnaire;Secondary Objective: A – evaluate effect of NAC on pancreatic function measured by blood, fecal , sweet, breath markers and correlate them to clinical outcome B – evaluate effect of NAC on hepatic cholestasis and necrosis evaluated by serum analisis and correlate them to clinical outcome C – evaluate effect of NAC in mucus composition, ROS production by lynphocytes;Primary end point(s): a. Evaluate effect of NAC on quality of life of patients affected by chronic pancreatitis at EORTC-QLQ C30 and PAN28 questionnaire b. Evaluate effect of NAC on quality of life of patients affected by primary sclerosing cholangitis at EORTC-QLQ C30 and BIL21 questionnaire;Timepoint(s) of evaluation of this end point: week 0/4/12/16

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: week 0/4/12/16;Secondary end point(s): A - In patients with chronic pancreatitis,analize effect of NAC on pancreatic function evaluated by levels of amilases, lipases, fecal elastasis and mixed triglicerid breath test (MTG breath test) B – in patient wth primary sclerosing cholangitis, analize the effect of NAC by alchaline phosphatase, g-glutmil transpeptidase, alanin amino transferase C – efficacy of NAC in modulate electrolytes in sweet test D – evaluate whether sweet electrolytes modulation is associated to better clinical outcome E - Evaluate whether NAC modulates quality of pancreatic mucus F - Evaluate whether NAC modulate ROS in peripheral blood lynphocytes	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: week 0/4/12/16;Secondary end point(s): A - In patients with chronic pancreatitis,analize effect of NAC on pancreatic function evaluated by levels of amilases, lipases, fecal elastasis and mixed triglicerid breath test (MTG breath test) B – in patient wth primary sclerosing cholangitis, analize the effect of NAC by alchaline phosphatase, g-glutmil transpeptidase, alanin amino transferase C – efficacy of NAC in modulate electrolytes in sweet test D – evaluate whether sweet electrolytes modulation is associated to better clinical outcome E - Evaluate whether NAC modulates quality of pancreatic mucus F - Evaluate whether NAC modulate ROS in peripheral blood lynphocytes

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Countries

Italy

Contacts

Public ContactMedicina interna e gastroenterologi

Policlinico Gemelli

agasbarrini@RM.UNICATT.IT0630156018

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026