A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption

McNeil Consumer and Specialty Pharmaceuticals0 个研究点目标入组 20 人开始时间: 2005年7月15日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•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 <15 micrograms fecal elastase/gram stool consistent with diagnosis of severe pancreatic insufficiency.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

发起方