Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 6:59 PM
Study NCT ID:
NCT05149833
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Study of Opioid Induced Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of opioid induced constipation (OIC)', 'timeFrame': '5 minutes', 'description': 'OIC diagnosed using Rome IV diagnostic criteria'}], 'secondaryOutcomes': [{'measure': 'Impact of OIC on quality of life', 'timeFrame': '5 minutes', 'description': 'Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)'}, {'measure': 'Efficacy of treatment for OIC', 'timeFrame': '3 minutes', 'description': 'Bowel Function Index tool score Score 0-100 (better to worse)'}, {'measure': 'Adherence with treatment for OIC No scale - yes / no options', 'timeFrame': '5 minutes', 'description': 'Study questionnaire'}, {'measure': 'Use of non-prescribed treatments for OIC', 'timeFrame': '5 minutes', 'description': 'Study questionnaire No scale - yes / no options'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-Induced Constipation']}, 'referencesModule': {'references': [{'pmid': '10474699', 'type': 'BACKGROUND', 'citation': 'Fallon MT, Hanks GW. Morphine, constipation and performance status in advanced cancer patients. Palliat Med. 1999 Mar;13(2):159-60. doi: 10.1191/026921699677653615. No abstract available.'}, {'pmid': '15781174', 'type': 'BACKGROUND', 'citation': 'Goodman M, Low J, Wilkinson S. Constipation management in palliative care: a survey of practices in the United kingdom. J Pain Symptom Manage. 2005 Mar;29(3):238-44. doi: 10.1016/j.jpainsymman.2004.06.013.'}, {'pmid': '19564094', 'type': 'BACKGROUND', 'citation': 'van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Quality of life and non-pain symptoms in patients with cancer. J Pain Symptom Manage. 2009 Aug;38(2):216-33. doi: 10.1016/j.jpainsymman.2008.08.014. Epub 2009 Jun 28.'}, {'pmid': '11331334', 'type': 'BACKGROUND', 'citation': 'Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.'}, {'pmid': '32701649', 'type': 'BACKGROUND', 'citation': 'Davies A, Leach C, Butler C, Gregory A, Henshaw S, Minton O, Shorthose K, Batsari KM. Opioid-induced constipation in patients with cancer: a "real-world," multicentre, observational study of diagnostic criteria and clinical features. Pain. 2021 Jan;162(1):309-318. doi: 10.1097/j.pain.0000000000002024.'}, {'pmid': '12229965', 'type': 'BACKGROUND', 'citation': 'Walter S, Hallbook O, Gotthard R, Bergmark M, Sjodahl R. A population-based study on bowel habits in a Swedish community: prevalence of faecal incontinence and constipation. Scand J Gastroenterol. 2002 Aug;37(8):911-6. doi: 10.1080/003655202760230865.'}, {'pmid': '24935009', 'type': 'BACKGROUND', 'citation': 'Lee TH, Choi SC, Park MI, Park KS, Shin JE, Kim SE, Jung KW, Koo HS, Kim WJ, Cho YK, Kim YS, Lee JS. Constipation misperception is associated with gender, marital status, treatment utilization and constipation symptoms experienced. J Neurogastroenterol Motil. 2014 Jul 31;20(3):379-87. doi: 10.5056/jnm14011.'}, {'pmid': '40071858', 'type': 'DERIVED', 'citation': "Davies A, Fagan N, Power J, Taylor A. 'Constipation': One word, many meanings amongst persons with cancer: An observational study. Palliat Med. 2025 May;39(5):553-562. doi: 10.1177/02692163251325711. Epub 2025 Mar 12."}]}, 'descriptionModule': {'briefSummary': 'Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure.\n\nOIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.', 'detailedDescription': "This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants may be inpatients, or outpatients at the study sites. Participants must meet all of the inclusion criteria for the study, and none of the exclusion criteria for the study. Participants must have a diagnosis of cancer and be on regular opioids for at least one week for cancer/ cancer treatment related pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or over\n* Diagnosis of cancer\n* Diagnosis of cancer pain or cancer treatment-related pain\n* Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid)\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Unable to complete questionnaire'}, 'identificationModule': {'nctId': 'NCT05149833', 'acronym': 'E-StOIC', 'briefTitle': 'European Study of Opioid Induced Constipation', 'organization': {'class': 'OTHER', 'fullName': 'University of Dublin, Trinity College'}, 'officialTitle': 'An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid Induced Constipation (OIC) in European Patients With Cancer Pain', 'orgStudyIdInfo': {'id': 'PM2021/65'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D6W EV82', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Norah Fagan', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Andrew Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dublin, Trinity College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Palliative Medicine', 'investigatorFullName': 'Prof Andrew Davies', 'investigatorAffiliation': 'University of Dublin, Trinity College'}}}}