A trial investigating a new CREON formulation of pancreatic enzyme replacement therapy medication in people with CF
Details
- Therapeutic approach
- Nutritional-GI
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- TT014413
- Last updated
- 16/10/2024
A clinical trial to evaluate acceptability of a new CREON formulation of pancreas powder gastro-resistant pellets in people with cystic fibrosis experiencing pancreatic exocrine insufficiency malfunction
Study detailsThis study will evaluate the acceptability of a new CREON formulation containing pancreas powder gastro-resistant pellets for oral intake.
Participants will be asked to attend 3 in person visits over the course of approximately 3 weeks. All participants will take standard CREON capsules with every meal and snack for 7 days. Then, all participants will take the test medication (new CREON formulation) for 8 days with every meal and snack. During both these periods, participants will be asked to complete paper-based diaries.
Following the completion of the 8 days on the test medication, participants will also take a paper-based questionnaire during the final in-person visit. 8 days after the last dose of the test medication, the research team will have a follow-up phone call with all participants to evaluate any complains, illnesses, or injuries.
- Phase
- Phase 1
- Length of participation
- Approximately 3 weeks
- Recruitment target
- 20
- CF sponsor
- Pharmalog
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
- 18 years and older with a diagnosis of cystic fibrosis (documented by two sweat tests or by gene analysis)
- Currently taking CREON capsules for pancreatic enzyme replacement, taking 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). Current dose is at least two CREON capsules per main meal
- Excluding people
- Evidence of severe disease, or any other relevant conditions (other than CF) which might limit participation in or completion of the study.
- History of allergic reaction or hypersensitivity to pancreatin or components of CREON or any pork or pig product.