A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Interventions
DRUG

Creon®

active comparator

DRUG

Creon N

experimental drug

Trial Locations (7)

1122

Research facility ID ORG-000826, Budapest

2045

Research facility ID ORG-000825, Törökbálint

4031

Research facility ID ORG-000816, Debrecen

7400

Research facility ID ORG-000827, Kaposvár

8035

Research facility ID ORG-000829, Barcelona

41013

Research facility ID ORG-000828, Seville

46026

Research facility ID ORG-000815, Valencia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY

NCT02137382 - A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Biotech Hunter | Biotech Hunter