Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI) MedDRA version: 9.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders
Conditions
Interventions
Product Name: ZENTASE
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Concentration unit: U unit(s)
Concentration type: equal
Concentratio
Sponsors
EURAND SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age over 18 3. Written, legally valid informed consent 4. Female patients must be using a medically acceptable form of birth control for the 30 days prior to the beginning of the study, have a negative pregnancy test prior to entering the study and agree to maintain adequate birth control measures during the whole duration of the study 5. Documented diagnosis of CP (ultrasound or X-Ray or CT scan or ERCP [Endoscopic Retrograde Cholangio-Pancreatograhy] or Endoscopic Ultrasound). 6. Documented EPI with FE ≤ 100 mcg/g of stool. If the FE test was performed in the six months preceding the date of the screening visit, the determination will not be repeated. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects known to the Investigator to have a significant medical and/or mental disease that would compromise the patient?s welfare, pose and unacceptable risk to him/her or confound the study results 2. Participation in a clinical trial within 30 days prior to start of study 3. Cystic fibrosis 4. Continuing excessive alcohol assumption or drug abuse 5. Inability to cooperate adequately, according to the Investigator 6. Use and inability to discontinue non allowed concomitant medication, such as antacids (including PPIs and H2-blockers), laxatives, cholestyramines or cholestyramine-like substances 7. Uncontrolled diabetes mellitus 8. Allergy to pork protein 9. Drug hypersensitivity, allergic asthma, urticaria, or other relevant allergic diathesis 10. Pregnancy or lactation 11. Acute pancreatitis or acute exacerbation of chronic pancreatitis 12. Acute affection of the bile tract, e.g. acute exacerbation of biliary pancreatitis 13. Malassimilation syndrome caused by a metabolic disease or by surgery, not related to exocrine pancreatic insufficiency 14. Previous partial or complete extensive resection (i.e capable of affecting transit time and/or gastric emptying) of the stomach or the intestinal tract, 15. Evidence of gastric or duodenal ulcer 16. Chronic inflammatory bowel disease 17. Any history of pancreatic carcinoma and other non cutaneous malignancies (any history of) 18. Viral hepatitis with infectious virions in blood and/or body fluids (any etiology) 19. HIV infection 20. Hyperuricemia ( > 1.5 times Upper Normal Value for lab) 21. Hyperuricosuria (> 1.5 times Upper Normal Value for lab) 22. Any acute or chronic disease, which in the opinion of the investigator could influence study results or pose a risk to the patient?s safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy Objectives The objective of the study is to evaluate the efficacy (compared to placebo) of Zentase? in the treatment of signs and symptoms of malabsorption in CP patients with EPI. Safety Objectives The safety objective is to compare the frequency, duration, and severity of treatment-emergent adverse events (AEs) and changes in clinical laboratory findings, following treatment with Zentase? compared to placebo.;Secondary Objective: Clinical Research Objectives The study will also explore a potential correlation between the levels of Fecal Elastase (FE) and Serum Trypsinogen (ST) in patients with CP and EPI, in an attempt to establish whether ST can be reliably used to diagnose EPI in CP patients.;Primary end point(s): The primary endpoint will be the mean improvement in the Coefficient of Fat Absorption (CFA) after administration of the ?high dose? of Zentase? vs. placebo, in the subset of evaluable patients with a significant degree of steatorrhea (CFA ≤ 65%) under placebo treatment. | — |
Countries
Italy
Outcome results
None listed