NCT02415959

Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

Detailed description

This study is a Phase II, randomized, parallel-group, active-controlled, double-blind, dose ranging, multicenter study with 4 different doses of Creon IR and one dose of the active control Creon® (DR/GR), administered in subjects of 12 years or older with PEI due to CF. The study is divided into two periods: a screening period of 14 days and a double-blind treatment period of 6 to 7 days.

Conditions

• Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Creon IR
DRUG	Creon® (DR/GR)

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-04-14
• Last updated: 2016-04-04
• Results posted: 2016-02-17

Locations

17 sites across 4 countries: Czechia, Hungary, Poland, Spain