Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption
Conditions
Interventions
Trade Name: Panzytrat® ok
Product Name: Pancrelipase Microtablets
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: Pancreatin
CAS Number: 8049-47-6
Concentration unit: IU internation
Sponsors
McNeil Consumer and Specialty Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and/or female infants/toddlers 6 to 24 months of age. 2. Diagnosis of CF confirmed by genetic testing including chromosomal analysis and/or clinical criteria including abnormal results of pilocarpine iontophoresis sweat testing consistent with diagnosis of CF. 3. Historical documentation of abnormal coefficient of fat absorption (COA) 4. Subject’s parent or legal guardian must sign informed consent. 5. Stable patient requiring enzyme therapy for management of steatorrhoea in subjects with defined diagnosis as set forth by criteria 2 and 3 6. Historical documentation of abnormal coefficient of fat absorption (COA) or presence of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Stable antibiotic therapy for small bowel overgrowth or chronic pulmonary infection. 2. Hypersensitivity to porcine products. 3. Use of prokinetics including metoclopramide or cisapride. 4. Concurrent nasogastric tube feeding for supplemental enteral nutrition. 5. Concomitant steroid therapy. 6. Exacerbation of chronic lung infections. 7. Use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy. 8. Use of herbal supplements. 9. Clinically significant vomiting, malnutrition, or severe dehydration. 10. Severe constipation and intestinal resection. 11. Uncorrected electrolyte disorders (such as hypokalaemia, hypocalcaemia, hypomagnesaemia). 12. Known chromosome abnormality or congenital anomalies of the gastrointestinal tract, heart or liver; including gastrointestinal tract abnormalities. 13. Clinically significant disease that could interfere with the adequate assessment of the study drug. 14. HIV infection. 15. History of drug sensitivity to any of the study medication ingredients; 16. Subject in any other investigational drug study within the previous 30 days of consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to evaluate preliminary safety, palatability and efficacy of pancrelipase microtablets to improve steatorrhoea in infants and toddlers with cystic fibrosis (CF).;Secondary Objective: None stated.;Primary end point(s): The primary endpoints will be: • the change in coefficient of fecal fat absorption (COA) measured from baseline to the end of study period. • assessment of daily palatability using a 4-point scale. • assessment of percentage of CO2 expired by a 13C-medium chain triglyceride breath test as a measure of exogenous lipase activity and as a surrogate marker of lipase activity and pharmacodynamic effect of pancreatic enzyme therapy. | — |
Countries
Belgium
Outcome results
None listed