CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Creon IR +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02415959
NCT02415959Phase 2Completed
CompareCT.gov

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

Abbott·interventional·Posted Apr 14, 2015·Updated Apr 4, 2016

In Brief

A Phase 2 clinical trial evaluating Creon IR and Creon® (DR/GR) for Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis. Completed, enrolled 70 participants across 17 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
CountriesCzechia, Hungary, Poland, Spain
CollaboratorsAbbVie, LKF Laboratorium für Klinische Forschung GmbH, Analytical Biochemical Laboratory, Parexel, Datamap, Linical Co., Ltd.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 14, 2015
Enrollment StartMar 1, 2015
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.2 years ago

Interventions

Creon IRdrug

Creon® (DR/GR)drug