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

NCT02415959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-04-04

Study results available
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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).

Conditions

  • Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Interventions

DRUG

Creon IR

DRUG

Creon® (DR/GR)

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • LKF Laboratorium für Klinische Forschung GmbH

    collaborator UNKNOWN

  • Analytical Biochemical Laboratory

    collaborator UNKNOWN

  • Parexel

    collaborator INDUSTRY

  • Datamap

    collaborator INDUSTRY

  • Linical Co., Ltd.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Suntje Sander-Struckmeier, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Czechia
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02415959 on ClinicalTrials.gov