Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-16 @ 5:58 AM
Study NCT ID:
NCT03697720
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D059265', 'term': 'Visceral Pain'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khellman@northshore.org', 'phone': '847-570-2622', 'title': 'Kevin Hellman, Research Associate Professor', 'organization': 'NorthShore University HealthSystem'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There was some loss to follow-up. We did not systematically query for adverse events.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Participants were asked to verbally relay any AEs they had experienced during the trial at follow-up. Please note, all-cause mortality or serious \\& other AEs were not formally queried, but we did monitor for them.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.\n\nNaproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia grade 1', 'notes': 'Nausea, upset stomach (mild, grade 1). Mild symptoms; intervention not indicated. Maybe unrelated to study drug as another new drug was being started at the same time.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTAE version 5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Menstrual Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.\n\nNaproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'The a priori threshold for statistical significance was .05', 'groupDescription': 'Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': '6-8 months', 'description': 'Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participant data were missing due to attrition'}, {'type': 'PRIMARY', 'title': 'Change in Participant Bladder Pain Sensitivity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.\n\nNaproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.119', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired t-test'}], 'paramType': 'MEAN', 'timeFrame': '6-8 months', 'description': 'Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participant data were missing due to attrition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.\n\nNaproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were recruited between April 2018 and December 2019 from our registry and other studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.\n\nNaproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menstrual Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Numeric Rating Scale is a 0-10 scale with 0 being no pain and 10 being the worst imaginable. Results from the NRS for worst day's menstrual pain are reported", 'unitOfMeasure': 'Numerical rating scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bladder Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '16.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Visual analog scale is a 0-100 scale with 0 being no pain and 100 worst pain imaginable. Results from the VAS of the bladder filling test are compared to determine if participants had a reduction in pain following treatment. Bladder pain ratings at first urge are used as the outcome measure.', 'unitOfMeasure': 'Visual Analog Scale 0-100', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '3 participants did not complete baseline visits to measure bladder pain'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-31', 'size': 424689, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-08T12:18', 'hasProtocol': True}, {'date': '2018-05-31', 'size': 279778, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-08T12:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2018-10-04', 'resultsFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-27', 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Menstrual Pain', 'timeFrame': '6-8 months', 'description': 'Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.'}, {'measure': 'Change in Participant Bladder Pain Sensitivity From Baseline', 'timeFrame': '6-8 months', 'description': 'Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cross-organ sensitivity', 'bladder pain', 'NSAID', 'visceral pain'], 'conditions': ['Dysmenorrhea', 'Pain']}, 'referencesModule': {'references': [{'pmid': '7011011', 'type': 'BACKGROUND', 'citation': 'Chan WY, Dawood MY, Fuchs F. Prostaglandins in primary dysmenorrhea. Comparison of prophylactic and nonprophylactic treatment with ibuprofen and use of oral contraceptives. Am J Med. 1981 Mar;70(3):535-41. doi: 10.1016/0002-9343(81)90576-3.'}, {'pmid': '28888592', 'type': 'BACKGROUND', 'citation': 'Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in dysmenorrhea: epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018 Apr;218(4):390-400. doi: 10.1016/j.ajog.2017.08.108. Epub 2017 Sep 6.'}, {'pmid': '31870730', 'type': 'BACKGROUND', 'citation': 'Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.', 'detailedDescription': 'Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.\n\nIn this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than \\*\\*\\* use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive-age women (age 18-45) with dysmenorrhea\n* Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers\n* Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament\n* Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)\n\nExclusion Criteria:\n\n* Presence of active pelvic or abdominal malignancies (primary or metastatic)\n* Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)\n* Active genitourinary infection in the last four weeks\n* Unable to read or comprehend the informed consent in English\n* Unwilling to complete study procedures\n* Presence of hypertension or risk for developing hypertension\n* Unwillingness to take naproxen and/or placebo\n* Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)\n* Formal urological diagnosis such as overactive bladder or bladder pain syndrome.'}, 'identificationModule': {'nctId': 'NCT03697720', 'briefTitle': 'Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Endeavor Health'}, 'officialTitle': 'Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain', 'orgStudyIdInfo': {'id': 'EH18-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary Dysmenorrhea', 'description': 'We will look at the effects of naproxen 500mg use on pain starting just before and during menses.', 'interventionNames': ['Drug: Naproxen']}], 'interventions': [{'name': 'Naproxen', 'type': 'DRUG', 'description': 'Participants will take naproxen 500mg BID before and for the first 3 days of their period.', 'armGroupLabels': ['Primary Dysmenorrhea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Frank Tu, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endeavor Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Director MIS/Clinical Professor', 'investigatorFullName': 'Frank Tu', 'investigatorAffiliation': 'Endeavor Health'}}}}