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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.
EU CTIS ID: 2023-503256-27-00
What this study is testing
Evaluation of acceptability of a new CREON formulation containing Pancreas Powder gastro-resistant pellets.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Lack of willingness or inability to co-operate adequately.
- 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 (e.g. lipase, amylase, protease, dimethicone, gelatin, xanthan gum, citric acid, red colorant), or any pork or pig product).
See the full eligibility 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.
- 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.
- Lack of willingness or inability to co-operate adequately.
- 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 (e.g. lipase, amylase, protease, dimethicone, gelatin, xanthan gum, citric acid, red colorant), or any pork or pig product).
- Evidence of rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
- Known predisposition to allergies (relevance as judged by the investigator).
- Positive β-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). 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.
- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Visit V1, as judged by 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.