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Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

NCT01865695 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-09-23

No results posted yet for this study

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.

Conditions

  • Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
  • Patients With Pancreatic Exocrine Insufficiency

Interventions

DRUG

Creon

Creon is a licensed product, manufactured by Abbott Laboratories, Inc. used for the therapeutic indication of pancreatic exocrine insufficiency. The route of administration is oral, with capsules being taken with main meals without chewing. The most commonly reported adverse reactions to Creon are gastrointestinal disorders of mild or moderate severity (up to 10% of patients). These include nausea, vomiting, constipation, diarrhoea and abdominal distension. An uncommon reaction (\<0.01%) of patients may develop skin reactions such as a rash or itching. No additional adverse drug reactions have been identified.

OTHER

Placebo

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David S Sanders, FRCP · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865695 on ClinicalTrials.gov