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Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865695
Recruitment Status : Terminated (Lack of participant enrolment)
First Posted : May 31, 2013
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE May 21, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
  • Quality of life [ Time Frame: 6 weeks ]
    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 ]
    body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase
Official Title  ICMJE Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
  • Patients With Pancreatic Exocrine Insufficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Creon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2013)
50
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865695
Other Study ID Numbers  ICMJE STH16190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S Sanders, FRCP Sheffield Teaching Hospitals NHS Foundation Trust
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP