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

• Register: EUCTR
• Last refreshed on: 2 June 2014
• Main ID: EUCTR2012-004170-26-IT
• Date of registration: 11/10/2012
• Prospective Registration: Yes
• Primary sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
• Public title: Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.
• Scientific title: Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.
• Date of first enrolment: 04/12/2012
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004170-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Italy

Contacts

• Name: Medicina interna e gastroenterologi
• Affiliation: Policlinico Gemelli

• Name: Medicina interna e gastroenterologi
• Affiliation: Policlinico Gemelli

Key inclusion & exclusion 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
10 – withdraw of informed consent


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Intervention(s)

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
Concentration number: 600-
Pharmaceutical form of the placebo: Effervescent tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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

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

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: week 0/4/12/16

Secondary ID(s)

1628/12

Source(s) of Monetary Support

Policlinico Gemelli