Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

NCT ID: NCT01865695

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Creon

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S Sanders, FRCP

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Department of Gastroenterology

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH16190

Identifier Type: -

Identifier Source: org_study_id