Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01004393
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2009-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], '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': 'C032257', 'term': 'methylnaltrexone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Masanori.Mori@sis.seirei.or.jp', 'phone': '81-53-474-2222', 'title': 'Masanori Mori, MD', 'organization': 'Seirei Hamamatsu General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 years and 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diaphoresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Laxation After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Rescue-free Laxation within 24 hours (n=12)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '72'}]}]}, {'title': 'Laxation within 48 hours (n=12)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Laxation After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Mean time to rescue-free laxation ≤4 hours (n=11)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.134', 'groupId': 'OG000'}]}]}, {'title': 'Mean time to rescue-free laxation ≤24 hours (n=11)', 'categories': [{'measurements': [{'value': '16', 'spread': '0.155', 'groupId': 'OG000'}]}]}, {'title': 'Mean time to laxation ≤48 hours (n=11)', 'categories': [{'measurements': [{'value': '20', 'spread': '0.087', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Average pain (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Average pain (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Average pain (24-48 hours) (n=12)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': '0-4 hours (n=12)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '4-24 hours (n=12)', 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': '24-48 hours (n=11)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Frequency of ≥ 1 laxation (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '65'}]}]}, {'title': 'Frequency of ≥ 1 laxation (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '68'}]}]}, {'title': 'Frequency of ≥ 1 laxation (24-48 hours) (n=11)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '90'}]}]}, {'title': 'Consistency (slight-very hard) (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '36'}]}]}, {'title': 'Consistency (slight-very hard) (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '36'}]}]}, {'title': 'Consistency (slight-very hard)(24-48 hours) (n=11)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}]}]}, {'title': 'Difficulty (severe-very severe) (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '68'}]}]}, {'title': 'Difficulty (severe-very severe)(4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '68'}]}]}, {'title': 'Difficulty (severe-very severe)(24-48hours) (n=11)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Severity (severe-very severe) (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '68'}]}]}, {'title': 'Severity (severe-very severe) (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '75'}]}]}, {'title': 'Severity (severe-very severe) (24-48 hours) (n=11)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '57'}]}]}, {'title': 'Distress (severe-very severe) (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '54'}]}]}, {'title': 'Distress (severe-very severe) (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '54'}]}]}, {'title': 'Distress (severe-very severe) (24-48 hours) (n=11)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'classes': [{'title': 'Satisfied-very satisfied (0-4 hours) (n=12)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '61'}]}]}, {'title': 'Satisfied-very satisfied (4-24 hours) (n=12)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '81'}]}]}, {'title': 'Satisfied-very satisfied (24-48 hours) (n=11)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylnaltrexone', 'description': 'Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2009-10-28', 'resultsFirstSubmitDate': '2015-06-14', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-29', 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '4 hours after the dose of subcutaneous methylnaltrexone'}], 'secondaryOutcomes': [{'measure': 'Laxation After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '24 and 48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Time to Laxation After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}, {'measure': 'Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone', 'timeFrame': '48 hours after the dose of subcutaneous methylnaltrexone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methylnaltrexone', 'Constipation', 'Narcotic Antagonists', 'Analgesics, Opioid', 'Neoplasms'], 'conditions': ['Neoplasms', 'Constipation', 'Opioid-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '27628064', 'type': 'DERIVED', 'citation': 'Mori M, Ji Y, Kumar S, Ashikaga T, Ades S. Phase II trial of subcutaneous methylnaltrexone in the treatment of severe opioid-induced constipation (OIC) in cancer patients: an exploratory study. Int J Clin Oncol. 2017 Apr;22(2):397-404. doi: 10.1007/s10147-016-1041-6. Epub 2016 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.', 'detailedDescription': 'Pain is one of the most common and important symptoms of cancer, often requiring opioid analgesics for control. However constipation is one of the most frequent and debilitating side effects of opioids, occurring in 40%-70% of patients being treated for chronic pain. Although laxatives are commonly used to manage opioid-induced constipation, these agents are not always effective or satisfactory. Methylnaltrexone bromide is a peripherally acting antagonist of the mu-opioid receptor. As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is limited. This allows methylnaltrexone to function as a peripherally-acting antagonist in the gastrointestinal tract without impacting opioid-mediated analgesic effects in the central nervous system. The efficacy and safety of methylnaltrexone in treating opioid-induced constipation in patients with advanced disease receiving palliative care has been demonstrated. However the efficacy of this agent has not been evaluated in more active patients who are earlier in their disease course. The present study will evaluate the efficacy and safety of methylnaltrexone for the relief of severe opioid-induced constipation in this population and will attempt to identify factors predictive of methylnaltrexone response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed neoplasm\n* 18 years of age or older\n* Have received opioids for analgesia for at least 2 weeks and been on a stable regimen of opioids and laxatives for 3 or more days before study entry\n* Fewer than three laxation during the preceding week and no laxation within 24 hours before study entry, or no laxation within 48 hours before study entry\n* Life expectancy of at least 6 months\n* World Health Organization Performance Status 0-3\n* Women of childbearing potential must have a negative pregnancy test\n* Breastfeeding should be discontinued prior to study entry\n* Ability to understand and the willingness to sign a written informed consent document.\n* Laboratory values within a week of study entry:\n\nAbsolute neutrophil count \\> 1,500/microliter Hemoglobin \\> 7 g/dL Platelet count \\> 100,000/microliter Calculated calcium \\< 10.5 mg/dL Calculated creatinine clearance \\> 30 mg.min Alanine aminotransferase \\< 3 x upper limit of normal (ULN) Aspartate aminotransferase \\< 3 x ULN Alkaline phosphatase \\< 2.5 x ULN Bilirubin \\< 1.5 x ULN\n\nExclusion Criteria:\n\n* Constipation not primarily caused by opioids, such as mechanical gastrointestinal obstruction or ongoing vinca alkaloid administration\n* Indwelling peritoneal catheter\n* Clinically active diverticular disease\n* Fecal impaction\n* Acute surgical abdomen\n* Fecal ostomy\n* Peritoneal carcinomatosis\n* Known hypersensitivity to methylnaltrexone, naltrexone, or naloxone\n* Administration of any investigational drug or experimental product within the previous 30 days\n* Initiation of a new bowel regimen or prokinetic agents within a week of study entry'}, 'identificationModule': {'nctId': 'NCT01004393', 'briefTitle': 'Methylnaltrexone for Opioid-induced Constipation in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients', 'orgStudyIdInfo': {'id': 'VCC 0911'}, 'secondaryIdInfos': [{'id': 'VCC 0911', 'type': 'OTHER', 'domain': 'Vermont Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylnaltrexone bromide', 'description': 'A single dose of methylnaltrexone will be administered subcutaneously to eligible subjects based on weight at the study entry. Since we will include subjects at all stages of cancer management, administering this study drug is considered experimental. We will use the dose approved by FDA, i.e., 0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg.', 'interventionNames': ['Drug: Methylnaltrexone bromide']}], 'interventions': [{'name': 'Methylnaltrexone bromide', 'type': 'DRUG', 'otherNames': ['Relistor'], 'description': 'Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose', 'armGroupLabels': ['Methylnaltrexone bromide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Steven Ades, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fletcher Allen Health Care / University of Vermont College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Steven Ades', 'investigatorAffiliation': 'University of Vermont'}}}}