A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Phase 3 Completed 40 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).

Timeline

Start: 2008-08
Primary completion: 2009-02
Completion: 2009-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pancrelipase	Protein / enzyme biologic	—	Oral

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Summary

Timeline

Drugs

Indications