Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-29 @ 1:35 AM
Study NCT ID:
NCT01055704
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
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A higher dosage of MNTX may be needed to produce a detectable effect on GI and colonic transit as well as bowel pattern in healthy subjects who are naive to opioid agonists during MNTX initiation.'}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': 'Methylnaltrexone 0.30 mg/kg', 'otherNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Codeine 30 mg', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burn or sting with injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Colonic Geometric Center at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.902', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.048', 'ciLowerLimit': '-0.835', 'ciUpperLimit': '0.739', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.389', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, 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An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T1/2 of Ascending Colon Emptying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '14.1', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.675', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.971', 'ciLowerLimit': '-11.415', 'ciUpperLimit': '7.472', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.669', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.591', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.280', 'ciLowerLimit': '-10.792', 'ciUpperLimit': '6.233', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.208', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender 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'14.1', 'groupId': 'OG001'}, {'value': '126.8', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '101.1', 'spread': '6.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.425', 'ciLowerLimit': '-64.097', 'ciUpperLimit': '-4.753', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.670', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.989', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.181', 'ciLowerLimit': '-26.962', 'ciUpperLimit': '26.598', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.240', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Geometric Center at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 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An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Geometric Center at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.151', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.728', 'ciLowerLimit': '-0.278', 'ciUpperLimit': '1.734', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.497', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.806', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.111', 'ciLowerLimit': '-0.795', 'ciUpperLimit': '1.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.448', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Filling at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '34.5', 'spread': '14.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.889', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.772', 'ciLowerLimit': '-23.678', 'ciUpperLimit': '27.223', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.583', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.274', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.607', 'ciLowerLimit': '-10.362', 'ciUpperLimit': '35.577', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.356', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'Percent of solids reaching the colon at 6 hours', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.236', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.214', 'ciLowerLimit': '-0.572', 'ciUpperLimit': '0.145', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.885', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.028', 'ciLowerLimit': '-0.412', 'ciUpperLimit': '0.357', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.190', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'daily', 'description': 'Stool frequency was self reported in a daily bowel pattern diary for 13 days.', 'unitOfMeasure': 'Stools', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Consistency as Reported From the Bristol Stool Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'OG001', 'title': 'Codeine 30 mg'}, {'id': 'OG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'OG003', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.497', 'ciLowerLimit': '-1.255', 'ciUpperLimit': '0.261', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.374', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}, {'pValue': '0.855', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.063', 'ciLowerLimit': '-0.756', 'ciUpperLimit': '0.630', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.342', 'groupDescription': 'Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Error degrees of freedom adjusted for number of missing values imputed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Daily', 'description': 'Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'FG001', 'title': 'Codeine 30 mg'}, {'id': 'FG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'FG003', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants included males and non-pregnant, non-breastfeeding females aged 18 to 55 years. All subjects had a minimum body mass index (BMI) of 22 kg/m2.', 'preAssignmentDetails': 'Subjects were screened for eligibility within 28 days of Day 1 of the study. They were stratified based on gender and BMI (\\<25, ≥25 kg/m2) and randomized into one of four treatment groups: Treatment groups were randomly assigned in fixed block sizes according to a schedule provided by the study statistician (ARZ). Allocation sequence was concealed'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylnaltrexone 0.30 mg/kg'}, {'id': 'BG001', 'title': 'Codeine 30 mg'}, {'id': 'BG002', 'title': 'Methylnaltrexone 0.30 mg/kg + Codeine 30 mg'}, {'id': 'BG003', 'title': 'Placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '2.7', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '3.6', 'groupId': 'BG003'}, {'value': '37.5', 'spread': '2.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2010-01-22', 'resultsFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-08', 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colonic Geometric Center at 24 Hours', 'timeFrame': '24 hours', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.'}], 'secondaryOutcomes': [{'measure': 'T1/2 of Ascending Colon Emptying', 'timeFrame': '24 hours'}, {'measure': 'T1/2 of Gastric Emptying of Solid', 'timeFrame': '4 hours'}, {'measure': 'Colonic Geometric Center at 4 Hours', 'timeFrame': '4 hours', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.'}, {'measure': 'Colonic Geometric Center at 48 Hours', 'timeFrame': '48 hours', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.'}, {'measure': 'Colonic Filling at 6 Hours', 'timeFrame': '6 hours', 'description': 'Percent of solids reaching the colon at 6 hours'}, {'measure': 'Stool Frequency', 'timeFrame': 'daily', 'description': 'Stool frequency was self reported in a daily bowel pattern diary for 13 days.'}, {'measure': 'Stool Consistency as Reported From the Bristol Stool Scale', 'timeFrame': 'Daily', 'description': 'Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methylnaltrexone', 'Codeine', 'Gastrointestinal motility', 'Colonic transit'], 'conditions': ['Gastric Motility Disorder']}, 'referencesModule': {'references': [{'pmid': '20839388', 'type': 'RESULT', 'citation': 'Wong BS, Rao AS, Camilleri M, Manabe N, McKinzie S, Busciglio I, Burton DD, Ryks M, Zinsmeister AR. The effects of methylnaltrexone alone and in combination with acutely administered codeine on gastrointestinal and colonic transit in health. Aliment Pharmacol Ther. 2010 Oct;32(7):884-93. doi: 10.1111/j.1365-2036.2010.04422.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects.\n\nThe hypotheses are:\n\n1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans.\n2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine', 'detailedDescription': 'Methodology\n\nFollowing the initial screening visit (visit 1), participants will be randomized to study medication, either 0.30mg/kg methylnaltrexone subcutaneously or placebo once daily and 30 mg codeine orally or placebo taken four times daily for a total of five days. Participants will be randomly assigned to study medication and allocation will be concealed. A urine pregnancy test will be performed for all females of child bearing potential within the 48 hours prior to the receipt of study medication. Note that females who are status post bilateral tubal ligation, hysterectomy or postmenopausal are exempted from this test. Study medication will be administered on study med days 1, 2 and 3 (visits 2, 3 and 4) at the Clinical Research Unit (CRU). Participants will return for scintigraphic assessment of gastric, small bowel and colonic transit of solids on study med days 4 and 5 (visits 5 and 6). The transit studies will be undertaken on over a 48 hour time period; no study medication is given on the final day of transit (visit 7).\n\nInvestigational product, dosage, mode of administration, duration of treatment\n\n0.30 mg/kg methylnaltrexone or placebo subcutaneously once daily and 30 mg codeine or placebo orally four times daily for five consecutive days.\n\nTreatment groups\n\n1. placebo + placebo (8 participants)\n2. placebo + codeine 120mg (8 participants)\n3. methylnaltrexone 0.30 mg/kg + placebo (16 participants)\n4. methylnaltrexone 0.30 mg/kg + codeine 120 mg (16 participants)\n\nEfficacy assessments\n\n1. Scintigraphic gastrointestinal and colonic transit\n2. Assessment of bowel pattern frequency and consistency made by the patient using the bowel pattern diary\n\nSafety assessments\n\nNo safety assessments (routine laboratory analysis, ECG etc) will be performed as both methylnaltrexone and codeine are FDA approved medications\n\nStatistical analysis\n\nThe overall effects of the methylnaltrexone treatment on the primary and secondary response measures will be assessed using an analysis of covariance (ANCOVA) with suitable transformation for skewness in the distributions of measured responses if necessary (e.g., ANCOVA on ranks or an arcsine square root transformation for the proportion of marker in the colon at 6 hours). The covariates considered for inclusion in the analyses will be age, gender and body mass index. An a priori anticipated contrast (overall drug vs. placebo) will be examined (α = 0.05). The specific comparisons of methylnaltrexone vs placebo and codeine vs codeine plus methylnaltrexone are of significant interest, and since they are related to specific hypotheses, no change in α from 0.05 is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Males and non-pregnant, non-breastfeeding females\n* 18-65 years old\n* No functional GI disorders on the short Bowel Disease Questionnaire (BDQ)\n* A BMI greater than 22.0\n\nExclusion criteria\n\n* Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders. The short version of the Bowel Disease Questionnaire (BDQ) will be exclude functional GI disorders. More than three positive responses will exclude participation.\n* Unable to withdraw from the following medications 48 hours prior to study entry:Any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants; analgesic drugs including opiates, NSAID, COX 2 inhibitors (note : Tylenol is permitted); GABAergic agents and benzodiazepines. Note: Concomitant medications will be reviewed on a case by case basis by the study physicians.\n* Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers. Alcohol must be avoided from seven days prior to beginning the study medication until the completion of the study.\n* Subjects who have participated in another clinical study within the past 30 days.\n* Clinical evidence (including physical exam and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.'}, 'identificationModule': {'nctId': 'NCT01055704', 'briefTitle': 'Effect of Methylnaltrexone on GI Transit in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effect of Methylnaltrexone on Gastrointestinal and Colonic Transit in Health', 'orgStudyIdInfo': {'id': '09-002996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylnaltrexone', 'interventionNames': ['Drug: Methylnaltrexone only']}, {'type': 'EXPERIMENTAL', 'label': 'Codeine', 'interventionNames': ['Drug: Codeine only']}, {'type': 'EXPERIMENTAL', 'label': 'Methylnaltrexone + codeine', 'interventionNames': ['Drug: Methylnaltrexone + codeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo + placebo']}], 'interventions': [{'name': 'Methylnaltrexone only', 'type': 'DRUG', 'otherNames': ['MNTX', 'Relistor'], 'description': '0.30 mg/kg subcutaneous injection daily', 'armGroupLabels': ['Methylnaltrexone']}, {'name': 'Codeine only', 'type': 'DRUG', 'description': '30 mg taken orally four times daily for 5 days', 'armGroupLabels': ['Codeine']}, {'name': 'Methylnaltrexone + codeine', 'type': 'DRUG', 'description': 'Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days', 'armGroupLabels': ['Methylnaltrexone + codeine']}, {'name': 'Placebo + placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Camilleri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Michael Camilleri, MD', 'oldOrganization': 'Mayo Clinic'}}}}