EUROPAC2 trial to investigate the efficacy of ANTOX(vers) 1.2 and MGCT (magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis. - EUROPAC2

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2006-000087-83-GB
• Date of registration: 04/12/2007
• Prospective Registration: Yes
• Primary sponsor: University of Liverpool
• Public title: EUROPAC2 trial to investigate the efficacy of ANTOX(vers) 1.2 and MGCT (magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis. - EUROPAC2
• Scientific title: EUROPAC2 trial to investigate the efficacy of ANTOX(vers) 1.2 and MGCT (magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis. - EUROPAC2
• Date of first enrolment: 19/12/2008
• Target sample size: 240
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000087-83
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria
1. Patients with pancreatitis diagnosed for at least one year.
2. Patients who have provided written informed consent
3. Patients who are willing to be followed up regularly for at least one year.
4. Patients who are able and willing to complete Quality of Life and Pain Assessment questionnaires
5. PAtients who are able and willing to provide urine and faecal samples within two weeks of each study visit
6. Patients aged 5 to 65 years of age.
7. Individuals with characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months).
8. Patients with documented HP, as proven by gene mutations in the PRSS1 gene, or patients with ICP and no mutations detected in the PRSS1 gene.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria
1. Patients that do not consent to be involved in the trial, or underage patients whose parents/guardians do not consent for them be involved in the trial.
2. Patients or parents/guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements.
3. Patients who are currently receiving treatment with antioxidants or magnesium tablets or who have had such treatment within the last 3 months.
4. Patients who are currently receiving treatment with oral hypoglycaemics or steroids or who have had such treatment within the last 3 months.
5. Patients with renal failure (serum creatinine = 200 µg/l).
6. Patients with atrio-ventricular-block.
7. Serum triglyceride levels = 1000 mg/dl.
8. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months.
9. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function.
10. Patients who are participating in another drug trial.
11. Patients who are pregnant.
12. All men and women of reproductive potential unless using at least two types of contraceptive precautions, one of which must be a condom
13. Lactating mothers.
14. Patients with any disorder that would prevent adequate absorption of the active treatment.
15. Patients suffering from schizophrenia.
16. Patients who smoke more than 20 cigarettes per day.



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

Health Condition(s) or Problem(s) studied

Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis
MedDRA version: 13.1 Level: HLT Classification code 10033646 Term: Acute and chronic pancreatitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1 Level: PT Classification code 10056976 Term: Hereditary pancreatitis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Magnesiocard 2.5mmol
Pharmaceutical Form: Film-coated tablet
CAS Number: 8000044179
Other descriptive name: MAGNESIUM ASPARTATE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 614.8-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: ANTOX (vers) 1.2
Product Code: ANTOX
Pharmaceutical Form: Coated tablet
CAS Number: 59029
Other descriptive name: TOCOPHEROL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
INN or Proposed INN: ASCORBIC ACID
CAS Number: 50817
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
CAS Number: 7782492
Other descriptive name: SELENIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: METHIONINE
CAS Number: 63683
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 480-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Secondary objectives

• Disruption of activities of normal living.
• Analgesic use for pancreatic pain.
• Number of days of hospitalisation for conditions related to pancreatitis.
• Quality of Life (QoL) measures.
• Markers of inflammatory response and activity of the pancreas.
• Changes in urinary levels of magnesium, selenium and vitamin C over the duration of the study.
• Antioxidant response as measured by urinary thiobarituric acid levels.
• Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
• Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, CFTR, other).

Main Objective: Primary objective

Redution in the number of days of pancreatic pain during 12 continuous months of treatment.

Primary end point(s): Reduction in the number of days of pancreatic pain during 12 continuous months of treatment.

Secondary ID(s)

ISRCTN44912429

2929

Secondary Sponsor(s)

The Royal Liverpool and Broadgreen University Hospitals NHS Trust

Ethics review

Status: Approved
Approval date:
Contact: