E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10033646 |
E.1.2 | Term | Acute and chronic pancreatitis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056976 |
E.1.2 | Term | Hereditary pancreatitis |
E.1.2 | System Organ Class | 10010331 - Congenital, familial and genetic disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective
Redution in the number of days of pancreatic pain during 12 continuous months of treatment. |
|
E.2.2 | Secondary objectives of the trial |
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).
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in the number of days of pancreatic pain during 12 continuous months of treatment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
end of trial is the last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |