Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT01367561
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2011-05-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'C032257', 'term': 'methylnaltrexone'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal force of detrusor contraction (Pdet) after administration of MNTX', 'timeFrame': '14 days', 'description': 'To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Males']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males, 18 to 65 yrs with normal urinary function\n2. Body weight less than 150 kg and Body Mass Index between 20-32.\n\nExclusion Criteria:\n\n1. Females\n2. History of drug or alcohol abuse\n3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.)\n4. Subjects who received opioids for one week or longer in the last 2 months.'}, 'identificationModule': {'nctId': 'NCT01367561', 'briefTitle': 'Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'MNTX 206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Naloxone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: IV Methylnaltrexone (MNTX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naloxone', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}, {'name': 'IV Methylnaltrexone (MNTX)', 'type': 'DRUG', 'armGroupLabels': ['Arm 2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Progenics Pharmaceuticals, Inc.', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}], 'overallOfficials': [{'name': 'Tage Ramakrishna, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progenics Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tage Ramakrishna, M.D.', 'oldOrganization': 'Progenics Pharmaceuticals, Inc.'}}}}