Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust (Other)

Overall Status

Terminated

CT.gov ID

NCT01865695

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment [6 weeks]

Secondary Outcome Measures

Quality of life [6 weeks]
Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment
body mass index [6 weeks]
body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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