Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT03316859
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naloxegol and Opioid-induced Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Post-operative day 1', 'description': 'CVICU length of stay'}, {'measure': 'Length of stay', 'timeFrame': 'Post-operative day 2', 'description': 'CVICU length of stay'}, {'measure': 'Length of stay', 'timeFrame': 'Post-operative day 3', 'description': 'CVICU length of stay'}, {'measure': 'Length of stay', 'timeFrame': 'Post-operative day 4', 'description': 'CVICU length of stay'}, {'measure': 'Length of stay', 'timeFrame': 'Post-operative day 5', 'description': 'CVICU length of stay'}], 'primaryOutcomes': [{'measure': 'Time to substantial bowel movement', 'timeFrame': 'Post-operative day 1', 'description': 'Time to bowel movement of Type 2 or higher on the Bristol stool chart'}, {'measure': 'Time to substantial bowel movement', 'timeFrame': 'Post-operative day 2', 'description': 'Time to bowel movement of Type 2 or higher on the Bristol stool chart'}, {'measure': 'Time to substantial bowel movement', 'timeFrame': 'Post-operative day 3', 'description': 'Time to bowel movement of Type 2 or higher on the Bristol stool chart'}, {'measure': 'Time to substantial bowel movement', 'timeFrame': 'Post-operative day 4', 'description': 'Time to bowel movement of Type 2 or higher on the Bristol stool chart'}, {'measure': 'Time to substantial bowel movement', 'timeFrame': 'Post-operative day 5', 'description': 'Time to bowel movement of Type 2 or higher on the Bristol stool chart'}], 'secondaryOutcomes': [{'measure': 'Rescue medications', 'timeFrame': 'Post-operative day 1', 'description': 'Amount of rescue medications'}, {'measure': 'Rescue medications', 'timeFrame': 'Post-operative day 2', 'description': 'Amount of rescue medications'}, {'measure': 'Rescue medications', 'timeFrame': 'Post-operative day 3', 'description': 'Amount of rescue medications'}, {'measure': 'Rescue medications', 'timeFrame': 'Post-operative day 4', 'description': 'Amount of rescue medications'}, {'measure': 'Rescue medications', 'timeFrame': 'Post-operative day 5', 'description': 'Amount of rescue medications'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid-induced constipation (OIC)'], 'conditions': ['Constipation', 'Constipation Drug Induced']}, 'referencesModule': {'references': [{'pmid': '24896818', 'type': 'BACKGROUND', 'citation': 'Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.'}, {'pmid': '25135384', 'type': 'BACKGROUND', 'citation': 'DePriest AZ, Miller K. Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014 Jun;3(1):1-15. doi: 10.1007/s40122-014-0026-2. Epub 2014 May 6.'}, {'pmid': '26136838', 'type': 'BACKGROUND', 'citation': 'Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Therap Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital\n* Admitted to Bethesda North TriHealth Hospital CVICU post-surgery\n\nExclusion Criteria:\n\n* Medically unstable\n* Cognitive deficits that impair the patient's ability to understand the informed consent\n* Language barriers\n* Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction\n* Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil\n* Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals\n* Conditions that present an increased risk of bowel perforation (as determined by the physician)\n* Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician"}, 'identificationModule': {'nctId': 'NCT03316859', 'briefTitle': 'Naloxegol and Opioid-induced Constipation', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation', 'orgStudyIdInfo': {'id': '17-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naloxegol', 'description': 'naloxegol 25 mg pill', 'interventionNames': ['Drug: Naloxegol 25 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo pill', 'interventionNames': ['Other: Placebo pill']}], 'interventions': [{'name': 'Naloxegol 25 MG', 'type': 'DRUG', 'otherNames': ['Movantik'], 'description': 'Naloxegol 25 mg administered 1 hour pre-operatively', 'armGroupLabels': ['Naloxegol']}, {'name': 'Placebo pill', 'type': 'OTHER', 'description': 'Placebo pill administered 1 hour pre-operatively', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jocelyn LaMar, BS', 'role': 'CONTACT', 'email': 'Jocelyn_LaMar@trihealth.com', 'phone': '513-865-5072'}], 'facility': 'Bethesda North TriHealth Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Jocelyn LaMar, BS', 'role': 'CONTACT', 'email': 'Jocelyn_LaMar@trihealth.com', 'phone': '513-865-5072'}, {'name': 'Jennifer Perkins', 'role': 'CONTACT', 'email': 'jennifer_perkins@trihealth.com', 'phone': '513-865-1415'}], 'overallOfficials': [{'name': 'Scott McCardle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bethesda North TriHealth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}