Pancreatic exocrine insufficiency Digestive System
Conditions
Interventions
This is an open-label single-arm, multicenter Phase I study testing a new CREON formulation of Pancreas Powder gastro-resistant pellets in the clinic of existing patients with cystic fibrosis (CF) who
Sponsors
Viatris
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects of any ethnic origin 2. At least 18 years of age 3. Cystic fibrosis (documented by two sweat tests or by gene analysis) 4. On treatment with PERT with CREON capsules on the current dose for at least 4 weeks before 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 5. Willing to comply with the requirements of the study protocol 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. 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 2. History of allergic reaction or hypersensitivity to pancreatin or excipients of CREON (e.g. lipase, amylase, protease, dimethicone, gelatin, xanthan gum, citric acid, red colorant), or any porc or pig product) 3. Known predisposition to allergies 4. 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). 5. Women on oral hormonal contraceptives or vaginal ring must agree to use another non-hormonal acceptable highly effective method of contraception in addition to the oral hormonal contraception or vaginal ring 6. Clinically relevant acute infections, febrile disease, or any acute condition (illness) two weeks prior to Visit 1 (V1), as judged by the investigator 7. Lack of suitability for the study: 7.1. History of alcohol or drug abuse within the last 2 years 7.2. Exposure to another investigational product within the last three months 8.0. Administrative reasons: 8.1. Lack of willingness to have personal study-related data collected, archived or 8.2. Transmitted according to protocol 9.3. Lack of willingness or inability to co-operate adequately 8.4. Anticipated non-availability for study visits/procedures 8.5. Vulnerable subjects (such as persons kept in detention) 8.6. Lack of ability or willingness to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of study treatment assessed at Visit 3 (Day 8) with a questionnaire (using an 11-point scale) containing 12 questions on handling, taste and convenience of taking the dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lipase dose and number of capsule/new formulation used, recorded in daily diary during the treatment period 2. Switch potential, measured using a questionnaire at Visit 3 (Day 8) 3. Clinical symptoms (stool frequency, stool consistency, abdominal pain and flatulence), recorded as a number or score in a daily diary during the treatment period 4. Adverse events and local tolerability (stomatitis, oral mucosal irritation, bleeding and ulcer assessed by investigator, pain in mouth assessed by subject) during the treatment period | — |
Countries
Germany, United Kingdom
Outcome results
None listed