Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142233
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2005-08-31
Brief Title:
EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Double Blind Randomised Controlled Trial to Investigate the Efficacy of ANTOX Vers 12 and MGCT Magnesiocard for the Treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-centre randomised phase III double blind placebo controlled parallel group outpatient study in patients diagnosed with hereditary pancreatitis and idiopathic chronic pancreatitis
The hypothesis to be tested is a 30 reduction in the number of days due to pancreatitis from 125 days per year to less than nine days per year under the treatment with magnesium or an antioxidant cocktail called ANTOX
A total of 288 patients will be randomised to one of three treatment groups in order to compare pancreatic pain over a twelve month period
The hypothesis to be tested is a 30 reduction in the number of days due to pancreatitis from 125 days per year to less than nine days per year under the treatment with magnesium or an antioxidant cocktail called ANTOX
A total of 288 patients will be randomised to one of three treatment groups in order to compare pancreatic pain over a twelve month period
Detailed Description:
Title EUROPAC 2 trial to investigate the efficacy of ANTOX vers 12 and MGCT Magnesiocard for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis
Study drug ANTOX vers 12 MGCT Magnesiocard
Intended indication Hereditary pancreatitis and idiopathic chronic pancreatitis
Study design A multi-centre double blind and placebo-controlled randomised parallel group study
Patient population Patients with hereditary pancreatitis or idiopathic chronic pancreatitis
Number of patients Total of 288 patients in three equal groups
Proposed number of initial centres two Greifswald Germany and Liverpool UK
Duration of dosing 12 months
Treatment groups
Group one Two ANTOX vers 12 tablets three times daily Antioxidant treatment 300 µg organic selenium 720 mg vitamin C 228 mg vitamin E 2880 mg methionine per day
Group two Two Magnesium-L-Aspartate-hydrochloride Magnesiocard 25 mmol MGCT tablets three times daily total dose 15 mmol 365 mg per day
Group three The same number of tablets as in Groups one and two but placebo instead of active drug
Efficacy parameters
Primary Pain number of days of pancreatic pain
Secondary Severity of pain analgesic use for pancreatic pain number of days of hospitalisation for conditions related to chronic pancreatitis quality of life markers of inflammatory response antioxidant response changes in urinary levels of magnesium selenium vitamin C and activity of the pancreatitis and pancreatic function
Safety parameters Toxicity Adverse events
Study drug ANTOX vers 12 MGCT Magnesiocard
Intended indication Hereditary pancreatitis and idiopathic chronic pancreatitis
Study design A multi-centre double blind and placebo-controlled randomised parallel group study
Patient population Patients with hereditary pancreatitis or idiopathic chronic pancreatitis
Number of patients Total of 288 patients in three equal groups
Proposed number of initial centres two Greifswald Germany and Liverpool UK
Duration of dosing 12 months
Treatment groups
Group one Two ANTOX vers 12 tablets three times daily Antioxidant treatment 300 µg organic selenium 720 mg vitamin C 228 mg vitamin E 2880 mg methionine per day
Group two Two Magnesium-L-Aspartate-hydrochloride Magnesiocard 25 mmol MGCT tablets three times daily total dose 15 mmol 365 mg per day
Group three The same number of tablets as in Groups one and two but placebo instead of active drug
Efficacy parameters
Primary Pain number of days of pancreatic pain
Secondary Severity of pain analgesic use for pancreatic pain number of days of hospitalisation for conditions related to chronic pancreatitis quality of life markers of inflammatory response antioxidant response changes in urinary levels of magnesium selenium vitamin C and activity of the pancreatitis and pancreatic function
Safety parameters Toxicity Adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None