Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT04173858
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589308', 'term': 'naloxegol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Quality of Life', 'timeFrame': '12 months', 'description': 'Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Assessment of Constipation Symptoms', 'timeFrame': '15 days', 'description': 'Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire'}, {'measure': 'Assessment of Constipation Symptoms', 'timeFrame': '1 month', 'description': 'Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire'}, {'measure': 'Assessment of Constipation Symptoms', 'timeFrame': '3 months', 'description': 'Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire'}, {'measure': 'Assessment of Constipation Symptoms', 'timeFrame': '6 months', 'description': 'Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Naloxegol, PAMORA'], 'conditions': ['Opioid-induced Constipation']}, 'descriptionModule': {'briefSummary': 'Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulatory oncology patients in Spain with diagnosis of OIC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Cancer\n* Treatment with opioids\n* OIC symptoms\n* Inadequate response to laxatives\n* Karnofsky equal or above 50\n* Ambulatory\n* Must be able to complete questionnaire forms\n\nExclusion Criteria: at the start of the study:\n\n* Hypersensitivity to Naloxegol or vehicle\n* Suspicion or high risk of gastrointestinal block\n* High risk of GI perforation\n* Severe liver failure\n* Pregnancy or breastfeeding\n* Use of potent CYP3A4 inhibitors\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04173858', 'acronym': 'KYONAL', 'briefTitle': 'Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Farmacéutica S.L.U.'}, 'officialTitle': 'Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study', 'orgStudyIdInfo': {'id': 'KYO-NAL-2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.', 'interventionNames': ['Drug: Naloxegol']}], 'interventions': [{'name': 'Naloxegol', 'type': 'DRUG', 'description': '25 mg oral naloxegol once daily.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28850', 'city': 'Torrejón de Ardoz', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Torrejon', 'geoPoint': {'lat': 40.45535, 'lon': -3.46973}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Farmacéutica S.L.U.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}