drugset / Trial / NCT02415959
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Phase 2
Completed
70 enrolled
Abbott
AbbVie · collabAnalytical Biochemical Laboratory · collabData Map GmbH · collabLKF Laboratorium für Klinische Forschung GmbH · collabLinical Co., Ltd. · collabParexel · collab
RandomizedParallel-groupTriple-blind
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).
Timeline
- Start
- 2015-03
- Primary completion
- 2015-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Creon IR | Unknown | 30000 iu | — |
| Subject | Creon IR | Unknown | 120000 iu | — |
| Subject | Creon IR | Unknown | 240000 iu | — |
| Subject | Creon IR | Unknown | 400000 iu | — |
| Comparator | Creon® (DR/GR) | Unknown | 400000 iu | — |