Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1 Level: HLGT Classification code 10015674 Term: Exocrine pancreas conditions System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Con
Conditions
Interventions
Trade Name: Kreon 25 000
Product Name: KREON 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pancreas Powder
CAS Number: 8
Sponsors
Aptalis Pharma US Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Definitive diagnosis of CF based on the following: - One clinical feature consistent with CF and - Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by quantitative pilocarpine iontophoresis; 2. Pancreatic insufficiency documented by a monoclonal faecal elastase 19 kg/m2 in adult subjects or a BMI percentile -10th percentile for age in adolescent (12 to 17 years age group) subjects; 5. Are clinically stable with no evidence of concomitant illness, or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study; 6. Subjects likely to adhere to a prescribed diet, vitamin, and nutritional supplements usage; 7. Dose stabilisation, defined as no change in the number of capsules taken per day for 3 consecutive days before the end of the Screening Period; 8. Willing to be switched from existing pancreatic enzyme treatment; 9. Women of childbearing potential must use a medically acceptable birth control method for the duration of the study (ie, from screening) and for 30 days thereafter; - Women who are not of childbearing potential will be defined as no attainment of menses, confirmed sterility, undergone surgical procedure (TAH and or oophorectomy), or have undergone menopause (12 consecutive months without menses and substantiated by an appropriate follicle stimulating hormone [FSH]/ luteinizing hormone [LH] test for subjects under 65 years of age); 10. Written informed consent obtained; and 11. Appropriate assent from the minor if consent is provided by parent/guardian according to national legal requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 43 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 43 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age <12 years; 2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs; 3. Current uncontrolled diabetes mellitus; 4. History of solid organ transplantation; 5. History of surgery affecting the bowel function and weight gain; 6. History or presence of fibrosing colonopathy; 7. History of any other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic, or endocrine disease, with sequelae and/or treatment requirements that could interfere with the results of the study; 8. Presence of hepatic insufficiency that in the opinion of the investigator could interfere with the conduct of the study. 9. Any acute respiratory infection in the previous 7 days requiring antibiotics; 10. Cancer or any other chronic disease with life expectancy <2 years; 11. Subjects treated with oral steroids in the last 8 weeks; 12. Subjects receiving nutritional supplements containing high doses (- 30%) of medium-chain triglycerides (MCTs) to maintain weight gain; 13. Subjects who, in the opinion of the investigator, have a significant medical and/or mental disease that would compromise the subject’s welfare, pose an unacceptable risk to him/her, or confound the study results; 14. Subjects with evidence of alcohol or drug abuse that, in the opinion of the investigator, could lead to noncompliance with study requirements, or subjects otherwise unable to understand the nature, scope, and possible consequences of the study; 15. Positive urine (dipstick) pregnancy test (for subjects of childbearing potential); 16. Pregnant or lactating women; 17. Subjects who have been previously enrolled in this study; 18. Participation in an interventional clinical study within 30 days of the screening visit or as applicable per specific country regulations/guidelines. Participation in observational studies is not an exclusion; 19. Presence of any condition known to increase faecal fat loss including but not limited to: celiac disease, Crohn’s disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple’s disease; 20. Presence of any uncontrolled condition known to increase faecal fat loss including celiac disease, Crohn's disease and lactose intolerance. 21. Subjects who require chronic treatment with narcotics; or 22. Subjects who cannot swallow size 00 capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of EPI associated with CF in subjects 12 years of age and older who are able to swallow the capsules whole.; Secondary Objective: Please enter information in English and add any other language that is applicable- Controlling signs and symptoms of EPI, including stool frequency, consistency, fat in stool, abdominal pain, bloating, and flatulence (as recorded in the subject diary); - Change in body weight; - Total cholesterol, calculated low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and fat-soluble vitamins A, D, and E; - Coefficient of nitrogen absorption (CNA); and - Impact on overall health, daily life, perceived well-being, and symptoms using the Cystic Fibrosis Questionnaire (CFQ). ;Primary end point(s): CFA = coefficient of fat absorption;Timepoint(s) of evaluation of this end point: At the end of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At the end of each treatment period ; Secondary end point(s): 1. Difference in change in body weight during the 2 treatment periods 2. Differences in the CNA during the 2 treatment periods 3. Incidences of clinical signs and symptoms of EPI 4. The difference in change in CFQ scale from baseline to the end of each treatment period 5. Effect on total cholesterol, calculated LDL-C, HDL-C, and fat-soluble vitamins A, D, | — |
Countries
Belgium, Bulgaria, Germany, Hungary, Italy, United Kingdom
Contacts
Public ContactGilles Chauviere
Aptalis Pharma SAS
Outcome results
None listed