Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-03-01 @ 3:21 AM
Study NCT ID:
NCT02782169
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2015-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hawaiimedab@gmail.com', 'phone': '808-983-6000', 'title': 'Family Planning Department', 'organization': 'University of Hawaii'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Pain Score Over Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Ibuprofen 800mg Tablets Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'summed number of tablets used by each participant over the 72 hour study period', 'unitOfMeasure': 'tablets', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Oxycodone/Acetominophen Tablets (5/325mg) Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'summed number of tablets used by each participant over the 72 hour study period', 'unitOfMeasure': 'tablets', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Ever Experiencing Different Symptoms During Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Blurred Vision', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Dry Mouth', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'classes': [{'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Neutral', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'No response', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Asked at time point of 24 hours', 'description': '5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': 'Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo capsule with excipient to match Pregabalin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.25', 'spread': '5.45', 'groupId': 'BG000'}, {'value': '27.19', 'spread': '6.02', 'groupId': 'BG001'}, {'value': '27.22', 'spread': '5.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], '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': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2015-11-30', 'resultsFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-17', 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Pain Score Over Study Period', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain'}], 'secondaryOutcomes': [{'measure': 'Number of Ibuprofen 800mg Tablets Used', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'summed number of tablets used by each participant over the 72 hour study period'}, {'measure': 'Number of Oxycodone/Acetominophen Tablets (5/325mg) Used', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'summed number of tablets used by each participant over the 72 hour study period'}, {'measure': 'Number of Participants Ever Experiencing Different Symptoms During Abortion', 'timeFrame': 'Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)', 'description': 'A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.'}, {'measure': 'Satisfaction With Analgesia', 'timeFrame': 'Asked at time point of 24 hours', 'description': '5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '35553047', 'type': 'DERIVED', 'citation': "Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2."}, {'pmid': '30095762', 'type': 'DERIVED', 'citation': 'Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B. Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):612-618. doi: 10.1097/AOG.0000000000002787.'}]}, 'descriptionModule': {'briefSummary': 'Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requested and consented for pregnancy termination by medical abortion\n* Willing and able to complete multiple electronic surveys\n\nExclusion Criteria:\n\n* Previous participation in this trial\n* Current use of pregabalin or gabapentin\n* Contraindication to medical abortion with mifepristone and misoprostol\n* Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin\n* Unable to understand and sign written informed consents in English'}, 'identificationModule': {'nctId': 'NCT02782169', 'briefTitle': 'Prophylactic Pregabalin to Decrease Pain During Medical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SFPRF15-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Pregabalin 300 mg capsule (over encapsulated to maintain blinding)', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsule with excipient to match Pregabalin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Women's Options Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}