drugset / Trial / NCT00217204
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption
Phase 2
Completed
18 enrolled
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers
Timeline
- Start
- 2005-07
- Primary completion
- —
- Completion
- 2006-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | 500 iu/kg | Oral |
| Subject | Pancrelipase | Protein / enzyme biologic | 1000 iu/kg | Oral |
| Subject | Pancrelipase | Protein / enzyme biologic | 1500 iu/kg | Oral |
| Subject | Pancrelipase | Protein / enzyme biologic | 2000 iu/kg | Oral |