Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-29 @ 5:42 PM
Study NCT ID:
NCT01032759
Status:
TERMINATED
Last Update Posted:
2016-03-14
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Memantine and Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'habib001@dm.duke.edu', 'phone': '9196686266', 'title': 'Dr. Ashraf Habib', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID', 'otherNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'TIA', 'notes': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '2.64', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Pain score (0=no pain, 10= worst possible pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 48 hour assessment.'}, {'type': 'PRIMARY', 'title': '24 hr Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hr', 'unitOfMeasure': 'mg morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 24 hour assessment.'}, {'type': 'SECONDARY', 'title': 'Opioid Related Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-24 h', 'description': 'Number of participants with postoperative nausea and vomiting.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Related Side Effects: Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-24 h', 'description': 'Number of participants who experienced pruritus.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperalgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '37', 'groupId': 'OG000'}, {'value': '54', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 48 h', 'description': 'Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a "painful," "sore," or "sharper" feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who had this outcome measured and documented'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'Number of participants who reported "very satisfied" or "somewhat satisfied"', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who had this outcome reported and documented.'}, {'type': 'SECONDARY', 'title': 'Chronic Post-surgical Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'timeFrame': '1 month, 3 month, 6 month', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected and therefore not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Completed 24 Hour Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Completed 48 Hour Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '77 participants signed consent, 63 participants were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Memantine', 'description': 'Memantine: 20 mg, BID'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: BID'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '7', 'groupId': 'BG000'}, {'value': '59', 'spread': '7', 'groupId': 'BG001'}, {'value': '59', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 77}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2009-12-14', 'resultsFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-15', 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hr Opioid Consumption', 'timeFrame': '24 hr'}], 'secondaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '48 hours', 'description': 'Pain score (0=no pain, 10= worst possible pain)'}, {'measure': 'Opioid Related Side Effects', 'timeFrame': '0-24 h', 'description': 'Number of participants with postoperative nausea and vomiting.'}, {'measure': 'Opioid Related Side Effects: Pruritus', 'timeFrame': '0-24 h', 'description': 'Number of participants who experienced pruritus.'}, {'measure': 'Hyperalgesia', 'timeFrame': 'Within 48 h', 'description': 'Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a "painful," "sore," or "sharper" feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '48 hours', 'description': 'Number of participants who reported "very satisfied" or "somewhat satisfied"'}, {'measure': 'Chronic Post-surgical Pain', 'timeFrame': '1 month, 3 month, 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Memantine is associated with improvement in pain relief after surgery.', 'detailedDescription': 'This prospective, randomized, controlled trial will investigate whether perioperative memantine has a postoperative analgesic effect following radical retropubic prostatectomy (RRP). 100-110 patients scheduled to undergo RRP at Duke will be assessed preoperatively for allodynia using Von Frey filaments, then stratified into two groups based on the presence or absence of allodynia. Patients in each group will then be randomized to receive either memantine 20 mg or placebo 30-60 minutes preoperatively, followed on postoperative day 1 with either memantine 10 mg in the morning and 10 mg in the evening for memantine patients, or placebo at the same intervals for placebo patients. Data such as morphine consumption, patient satisfaction and pain scores, opioid-related side effects, and the area of hyperalgesia around the surgical incision will be recorded for the initial 48 hours postoperatively, and patient satisfaction with their postoperative analgesia will be assessed after 1 week. At 1, 3, and 6 months postoperatively, patients will be asked about the presence and intensity of any persistent pain related to surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male\n* Age 18 to 75 years old\n\nExclusion Criteria:\n\n* Chronic pain conditions or taking regular analgesics\n* Taking psychotropic medications\n* Parkinson's disease\n* Narrow-angle glaucoma\n* Known gastroduodenal ulcer\n* History of seizure disorder\n* Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL\n* Liver disease, including liver failure, cirrhosis, or acute hepatitis\n* Significant coronary vascular disease or cardiac conduction system disease, as noted by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%\n* American Society of Anesthesiologists (ASA) score of 4 or higher\n* Allergy to ketorolac or memantine"}, 'identificationModule': {'nctId': 'NCT01032759', 'briefTitle': 'Memantine and Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Memantine for Postoperative Analgesia', 'orgStudyIdInfo': {'id': 'Pro00019279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Memantine', 'interventionNames': ['Drug: Memantine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Memantine', 'type': 'DRUG', 'description': '20 mg, BID', 'armGroupLabels': ['Memantine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}