Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01293656
Status:
WITHDRAWN
Last Update Posted:
2015-06-02
First Post:
2011-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites.", 'timeFrame': '1 Year'}, {'measure': 'The number of participants with different degrees of CD and UC severity.', 'timeFrame': '1 Year'}, {'measure': 'Use rates of classes of drug therapy.', 'timeFrame': '1 Year'}, {'measure': 'Number and types of surgical interventions.', 'timeFrame': '1 Year'}, {'measure': 'Outcomes of surgical intervention.', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with CD or UC who visit the study sites in Eastern Europe, Middle East, and North Africa during the study period will be asked to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of Crohn's disease or ulcerative colitis."}, 'identificationModule': {'nctId': 'NCT01293656', 'briefTitle': "Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)', 'orgStudyIdInfo': {'id': 'P08166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD and UC participants', 'description': 'All participants with CD or UC visiting their physician over a period of one year, newly and already diagnosed, regardless of treatment pattern.', 'interventionNames': ['Other: No intervention.']}], 'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': 'There is no study intervention. Participants will be treated locally per site standards.', 'armGroupLabels': ['CD and UC participants']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}