Creon in patients with pancreatic insuffiency

Phase 1

• Conditions: Pancreatic Insufficiency; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-006019-73-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Study Completion: 2015-05-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

Patients with chronic diarrhoea (>3 loose/ liquid motions a day for more than 4 weeks)
Patients with a low faecal elastase (<200 µg/g),
Patients aged 16 years or over
Patients able to give written consent to participate
Patients not currently on Creon
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: What is the effect of Creon in patients with low faecal pancreatic elastase?<br><br> 1) Creon being the IMP we propose to evaluate in this study.<br> 2) Low faecal pancreatic elastase being a marker of pancreatic insufficiency<br><br> ;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;<br> Primary end point(s): Outcome Measures<br><br> Primary: Effect of Creon on stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment<br> ;Timepoint(s) of evaluation of this end point: 1 year after commencing recruitment

Secondary Outcome Measures

Name	Time	Method
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