Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03523520
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032257', 'term': 'methylnaltrexone'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'C000589308', 'term': 'naloxegol'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'goddardk@health.missouri.edu', 'phone': '5738841605', 'title': 'Dr. Kara B. Goddard', 'organization': 'University of Missouri Health Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Methylnaltrexone Oral Tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Methylnaltrexone Subcutaneous Injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \\[RELISTOR\\]\\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Naloxegol Oral Tablets', 'description': 'Naloxegol oral tablets (total 25 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nNaloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Bowl Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone Oral Tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet'}, {'id': 'OG001', 'title': 'Methylnaltrexone Subcutaneous Injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \\[RELISTOR\\]\\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution'}, {'id': 'OG002', 'title': 'Naloxegol Oral Tablets', 'description': 'Naloxegol oral tablets (total 25 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nNaloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who had a successful bowl movement within 24 hours of administration of study drug'}, {'type': 'SECONDARY', 'title': 'Time to Bowl Movement Within 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone Oral Tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet'}, {'id': 'OG001', 'title': 'Methylnaltrexone Subcutaneous Injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \\[RELISTOR\\]\\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution'}, {'id': 'OG002', 'title': 'Naloxegol Oral Tablets', 'description': 'Naloxegol oral tablets (total 25 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nNaloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '292.5', 'spread': '385.4', 'groupId': 'OG000'}, {'value': '256.5', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '270.2', 'spread': '187.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after administration of study drug', 'description': 'The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylnaltrexone Oral Tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet'}, {'id': 'FG001', 'title': 'Methylnaltrexone Subcutaneous Injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \\[RELISTOR\\]\\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution'}, {'id': 'FG002', 'title': 'Naloxegol Oral Tablets', 'description': 'Naloxegol oral tablets (total 25 mg)\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nNaloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylnaltrexone Oral Tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet'}, {'id': 'BG001', 'title': 'Methylnaltrexone Subcutaneous Injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nMethylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \\[RELISTOR\\]\\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution'}, {'id': 'BG002', 'title': 'Naloxegol Oral Tablets', 'description': 'Naloxegol oral tablets (total 25 mg) + subcutaneous water injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.\n\nNaloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53.3', 'spread': '28.3', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '18.8', 'groupId': 'BG002'}, {'value': '57.8', 'spread': '20.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-18', 'size': 140723, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-09T14:58', 'hasProtocol': True}, {'date': '2024-09-04', 'size': 88281, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-04T14:50', 'hasProtocol': False}, {'date': '2020-04-19', 'size': 4611346, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-06T21:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Each participant will be receiving one injection and tablets which have been randomly assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2018-05-01', 'resultsFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-04', 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Bowl Movement', 'timeFrame': '24 hours', 'description': 'The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.'}], 'secondaryOutcomes': [{'measure': 'Time to Bowl Movement Within 24 Hours', 'timeFrame': '24 hours after administration of study drug', 'description': 'The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constipation', 'opioid'], 'conditions': ['Constipation Drug Induced']}, 'referencesModule': {'references': [{'pmid': '29207909', 'type': 'BACKGROUND', 'citation': 'Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5.'}, {'pmid': '26150678', 'type': 'RESULT', 'citation': 'Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6.'}, {'pmid': '26312011', 'type': 'RESULT', 'citation': 'Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.', 'detailedDescription': 'Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)\n* Ageā„18y/o\n* Not pregnant or lactating (negative urinary pregnancy test)\n* No contraindication to Methylnaltrexone or Naloxegol\n\nExclusion Criteria:\n\n* Age\\<18y/o\n* Pregnancy or lactation\n* Contraindication to Methylnaltrexone or Naloxegol\n* Assigned NPO\n* Small bowel obstruction'}, 'identificationModule': {'nctId': 'NCT03523520', 'briefTitle': 'Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department', 'orgStudyIdInfo': {'id': '2011409 HS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylnaltrexone oral tablets', 'description': 'Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.', 'interventionNames': ['Drug: Methylnaltrexone Bromide 150 mg Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylnaltrexone subcutaneous injection', 'description': 'Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.', 'interventionNames': ['Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naloxegol oral tablets', 'description': 'Naloxegol oral tablets (total 25 mg) + subcutaneous water injection\n\nEligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.', 'interventionNames': ['Drug: Naloxegol 25 MG Oral Tablet']}], 'interventions': [{'name': 'Methylnaltrexone Bromide 150 mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Relistor'], 'description': 'Methylnaltrexone Bromide 150 mg Oral Tablet', 'armGroupLabels': ['Methylnaltrexone oral tablets']}, {'name': 'Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1', 'type': 'DRUG', 'otherNames': ['Relistor'], 'description': 'Methylnaltrexone Bromide 12 MG Subcutaneous Solution', 'armGroupLabels': ['Methylnaltrexone subcutaneous injection']}, {'name': 'Naloxegol 25 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['Movantik'], 'description': 'Naloxegol 25 MG Oral Tablet', 'armGroupLabels': ['Naloxegol oral tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kara B. Goddard', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'KARA B GODDARD, PharmD, BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSITY OF MISSOURI HEALTH CARE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Specialist', 'investigatorFullName': 'Kara B. Goddard, PharmD, BCPS', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}