Open-label single-arm, multicenter clinical trial to evaluate patient acceptability of a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis suffering from pancreatic exocrine insufficiency.

Phase 1

Recruiting

• Conditions: MedDRA version: 21.0Level: PTClassification code: 10079428Term: Cystic fibrosis gastrointestinal disease Class: 100000004850; patients with cystic fibrosis suffering from pancreatic exocrine insufficiency; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-503256-27-00
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Male and female subjects of any ethnic origin, At least 18 years of age, Cystic fibrosis (documented by two sweat tests or by gene analysis), On treatment with PERT with CREON capsules on the current dose for at least 4 weeks prior to entry in the study and with satisfactory symptom control (e.g. stool frequency and consistency, meteorism/flatulence, abdominal pain) with a dose of at least two CREON capsules per main meal, Willing to comply with the requirements of the study protocol., Written informed consent.

Exclusion Criteria

Evidence of severe disease, or any other relevant condition (other than CF) as revealed by history or physical examination which might limit participation in or completion of the study., Anticipated non-availability for study visits/procedures., Vulnerable subjects (such as persons kept in detention)., Lack of ability or willingness to give informed consent., History of allergic reaction or hypersensitivity to pancreatin or excipients of CREON or any porc or pig product., Known predisposition to allergies., Positive ß-human chorionic gonadotropin (HCG) pregnancy test, established pregnancy, or breast-feeding at Visit V1. Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant)., Clinically relevant acute infections, febrile disease, or any acute condition (illness) two weeks prior to Visit 1 (V1), as judged by the investigator., History of alcohol or drug abuse within the last 2 years., Exposure to another investigational product within the last three months., Lack of willingness to have personal study-related data collected, archived or transmitted according to protocol., Lack of willingness or inability to co-operate adequately.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified