Pancreatic exocrine Insufficiency due to Cystic Fibrosis
Conditions
Interventions
Product Name: CREON N 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not applicable
CAS Number: 8049-47-6
Current Sponsor code: CREON N
Other descriptive name: PANCREATIN
Concentration
Sponsors
Abbott Laboratories GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject 2. Age = 12 years 3. Subjects who are able to swallow capsules with each meal and snacks 4. Diagnosis of CF confirmed by two positive chloride sweat tests or gene analysis 5. Diagnosis of pancreatic exocrine insufficiency proven by: a. CFA =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study 2. History of acute abdomen 3. History of fibrosing colonopathy 4. History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment 5. Solid organ transplant or surgery affecting the large bowel other than appendectomy 6. Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy) 7. Pregnancy or lactation 8. Any type of malignancy involving the digestive tract in the last 5 years 9. Celiac disease or Crohn’s disease 10. Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules 11. Suspected non-compliance or non-cooperation 12. Intake of experimental drugs within 30 days prior to study start 13. Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject’s participation in or ability to complete the study 14. Diagnosis of human immunodeficiency virus in medical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the therapeutic equivalence of Creon N 25000 with Creon® 25000 on coefficient of fat absorption (CFA) in adolescent and adult subjects with pancreatic exocrine insufficiency (PEI) due to cystic fibrosis (CF).;Secondary Objective: To investigate the effect of Creon N 25000 and Creon® 25000 on coefficient of nitrogen absorption (CNA),on stool fat and clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence). Safety Objectives: To evaluate the short-term safety of Creon N 25000 and Creon® 25000, including vital signs, body weight, physical examination, safety laboratory values, and adverse events (AEs). ;Primary end point(s): The primary efficacy criterion is the CFA. CFA will be calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake – fat excretion] / fat intake ;Timepoint(s) of evaluation of this end point: The CFA values will be compared between the Creon N 25000 and Creon® 25000 treatment periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Secondary efficacy criteria are the coefficient of nitrogen absorption (CNA), stool fat and clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence). The safety data collected during the study are vital signs, physical examination, safety laboratory values and adverses events. ;Timepoint(s) of evaluation of this end point: The values will be compared between the Creon N 25000 and Creon® 25000 treatment periods. Safety parameters are assessed throughout the study. | — |
Countries
Hungary, Russian Federation, Spain
Contacts
Public ContactSenior Clinical Trial Manager
Abbott Laboratories GmbH
Outcome results
None listed