drugset
drugset / Trial / NCT00662675

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

NCT00662675 ↗

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

Outcome

Met primary endpoint

registry Placebo vs PANCREASE MT; p <0.001; ANCOVA NCT00662675 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic — Oral

Indications

cystic fibrosis exocrine pancreatic insufficiency malabsorption syndrome steatorrhea