Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01865695
First received: May 21, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
Patients With Pancreatic Exocrine Insufficiency
Drug: Creon
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

  • body mass index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.
Other: Placebo
Active Comparator: Creon
Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with coeliac disease and having chronic diarrhoea (>3 loose/ liquid motions a day for more than 4 weeks)
  • Patients with a low faecal elastase (<200 ug/g),
  • Patients aged 16 years or over
  • Patient able to give written consent to participate
  • Patient not currently on Creon

Exclusion Criteria:

  • Patients with normal faecal elastase (> 201ug/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
  • Patients who are unable to speak or understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865695

Contacts
Contact: David S Sanders, FRCP david.sanders@sth.nhs.uk
Contact: Matthew Kurien, MRCP mattkurien@hotmail.com

Locations
United Kingdom
Department of Gastroenterology Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: David S Sanders, FRCP       david.sanders@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Abbott
Investigators
Principal Investigator: David S Sanders, FRCP Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01865695     History of Changes
Other Study ID Numbers: STH16190
Study First Received: May 21, 2013
Last Updated: July 30, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
pancreatic exocrine insufficiency
faecal elastase
diarrhoea
coeliac
creon
gastrointestinal

Additional relevant MeSH terms:
Celiac Disease
Diarrhea
Exocrine Pancreatic Insufficiency
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Pancreatic Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014