Creon in patients with pancreatic insuffiency

Randomized, double blind, placebo-controlled trial of Creon in patients with low faecal pancreatic elastase - Creon use in patients with low faecal pancreatic elastase

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006019-73-GB

Enrollment

Registered

2012-09-24

Start date

2012-11-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Insufficiency

Interventions

Product Name: Creon Pharmaceutical Form: Capsule INN or Proposed INN: pancreatin PhEur 300mg Other descriptive name: Creon 25000 Capsules

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic diarrhoea (>3 loose/ liquid motions a day for more than 4 weeks) Patients with a low faecal elastase (=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Patients with normal faecal elastase (> 201µg/g), Patients under the age of 16 Patients allergic to pork or any pig product (advice from the drug manufacturer) Patients that are pregnant or are breast-feeding Patients taking alternative medication that could affect bowel frequency Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the effect of Creon in patients with low faecal pancreatic elastase? 1) Creon being the IMP we propose to evaluate in this study. 2) Low faecal pancreatic elastase being a marker of pancreatic insufficiency ;Secondary Objective: What is the effect of Creon on quality of life, gastrointestinal symptoms and on body mass index (BMI)in patients with low faecal pancreatic elastase; Primary end point(s): Outcome Measures Primary: Effect of Creon on stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment ;Timepoint(s) of evaluation of this end point: 1 year after commencing recruitment	—

Measure

Time frame

Main Objective: What is the effect of Creon in patients with low faecal pancreatic elastase? 1) Creon being the IMP we propose to evaluate in this study. 2) Low faecal pancreatic elastase being a marker of pancreatic insufficiency ;Secondary Objective: What is the effect of Creon on quality of life, gastrointestinal symptoms and on body mass index (BMI)in patients with low faecal pancreatic elastase; Primary end point(s): Outcome Measures Primary: Effect of Creon on stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment ;Timepoint(s) of evaluation of this end point: 1 year after commencing recruitment

—

Secondary

Measure	Time frame
Secondary end point(s): Effect of Creon on patient’s quality of life, body mass index and on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment;Timepoint(s) of evaluation of this end point: 1 year after commencing recruitment	—

Countries

United Kingdom

Contacts

Public ContactJim Lithgow

Sheffield Teaching Hospitals NHS Foundation Trust

jim.lithgow@sth.nhs.uk0114 2265424

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026