Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-23 @ 5:49 PM
Study NCT ID:
NCT01865695
Status:
TERMINATED
Last Update Posted:
2019-09-23
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020799', 'term': 'Pancrelipase'}], 'ancestors': [{'id': 'D008049', 'term': 'Lipase'}, {'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of participant enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '6 weeks', 'description': 'Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment'}, {'measure': 'body mass index', 'timeFrame': '6 weeks', 'description': 'body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic exocrine insufficiency', 'faecal elastase', 'diarrhoea', 'coeliac', 'creon', 'gastrointestinal'], 'conditions': ['Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)', 'Patients With Pancreatic Exocrine Insufficiency']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with coeliac disease and having chronic diarrhoea (\\>3 loose/ liquid motions a day for more than 4 weeks)\n* Patients with a low faecal elastase (\\<200 ug/g),\n* Patients aged 16 years or over\n* Patient able to give written consent to participate\n* Patient not currently on Creon\n\nExclusion Criteria:\n\n* Patients with normal faecal elastase (\\> 201ug/g),\n* Patients under the age of 16\n* Patients allergic to pork or any pig product (advice from the drug manufacturer)\n* Patients that are pregnant or are breast-feeding\n* Patients taking alternative medication that could affect bowel frequency\n* Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial\n* Patients who are unable to speak or understand English'}, 'identificationModule': {'nctId': 'NCT01865695', 'briefTitle': 'Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase', 'orgStudyIdInfo': {'id': 'STH16190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Creon', 'description': '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.', 'interventionNames': ['Drug: Creon']}], 'interventions': [{'name': 'Creon', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Creon']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Department of Gastroenterology', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'David S Sanders, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}