Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

NCT01865695 | Terminated Phase 4 DMC

• 1 other identifier: STH16190
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

pancreatic exocrine insufficiency; faecal elastase; diarrhoea; coeliac; creon; gastrointestinal

Outcome Measures

Primary Outcomes (1)

• Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment

  6 weeks

Secondary Outcomes (2)

• Quality of life

  6 weeks

• body mass index

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Creon

ACTIVE COMPARATOR

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

Interventions

Creon 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.

Creon

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Department of Gastroenterology

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Diarrhea

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• David S Sanders, FRCP

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

GB (1)