Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 5:28 PM
Study NCT ID:
NCT01143766
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2010-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gcote@iupui.edu', 'phone': '317-944-2740', 'title': 'Gregory A. Cote', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited sample size due to challenges with recruitment and transition to propofol-based anesthesia for sedation in ERCP. Study terminated at 50% enrollment for this reason.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.', 'otherNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.', 'otherNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoxemia or apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dosing Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'OG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '125'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '150'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.', 'unitOfMeasure': 'TOTAL DOSE OF MEPERIDINE, mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TOTAL DOSE OF MEPERIDINE'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sedation-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.\n\nStandard sedation regimen: Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.'}, {'id': 'OG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.\n\nGabapentin: gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Sedation-related adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Pain Score at Time of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'OG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Anxiety Score at Time of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'OG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Nausea Score at Time of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'OG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'FG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.'}, {'id': 'BG001', 'title': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2010-06-11', 'resultsFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-06', 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosing Requirements', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Sedation-Related Adverse Events', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Sedation-related adverse events'}, {'measure': 'Median Pain Score at Time of Discharge', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain).'}, {'measure': 'Median Anxiety Score at Time of Discharge', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety).'}, {'measure': 'Median Nausea Score at Time of Discharge', 'timeFrame': 'At time of discharge post-procedure', 'description': 'Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sedation', 'Gabapentin', 'ERCP', 'Endoscopy'], 'conditions': ['Conscious Sedation']}, 'descriptionModule': {'briefSummary': 'The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP) involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation. There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain, higher patient satisfaction and lower opiate requirements. The investigators are conducting a clinical trial to study this hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients \\>18 years of age referred to IUMC for first-time ERCP procedure.\n\nExclusion Criteria:\n\n1. Pregnant women\n2. age \\<18 years\n3. Incarcerated individuals\n4. Patients currently taking or having taken gabapentin or pregabalin within the last 3 months\n5. Patients unable to give informed consent\n6. Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction.\n7. High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class \\> 3.\n8. Patients undergoing general anesthesia for their ERCP procedure\n9. Patients receiving propofol sedation for their ERCP procedure'}, 'identificationModule': {'nctId': 'NCT01143766', 'briefTitle': 'Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0911-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard sedation', 'description': 'Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.', 'interventionNames': ['Other: Standard sedation regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gapabentin', 'description': 'Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.', 'interventionNames': ['Drug: Gabapentin']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'description': 'gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure', 'armGroupLabels': ['Gapabentin']}, {'name': 'Standard sedation regimen', 'type': 'OTHER', 'description': 'Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.', 'armGroupLabels': ['Standard sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Hospital, Indiana University Purdue University Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Gregory A Cote, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Medicine', 'investigatorFullName': 'Gregory A. Cote', 'investigatorAffiliation': 'Indiana University'}}}}