Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT01865695
Status:
TERMINATED
Last Update Posted:
2019-09-23
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of participant enrolment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (\<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: