A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002

• Conditions: Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI); MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disorders

• Registration Number: EUCTR2008-000061-37-IT
• Lead Sponsor: EURAND SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified