Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT01171794
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lipmangrant@gmail.com', 'phone': '4152909286', 'title': 'Grant S Lipman ( PI)', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ibuprofen', 'description': 'Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'visually identical placebo', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Mountain Sickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen', 'description': 'Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'visually identical placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 days', 'description': 'Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants meeting all inclusion criteria were analyzed'}, {'type': 'PRIMARY', 'title': 'Acute Mountain Sickness Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen', 'description': 'Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'visually identical placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants meeting all inclusion criteria were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibuprofen', 'description': 'Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Visually identical placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibuprofen', 'description': 'Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Visually identical placebo'}, {'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': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '36.6', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants meeting all inclusion criteria were analyzed'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2010-07-27', 'resultsFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-09', 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Mountain Sickness', 'timeFrame': '2 days', 'description': 'Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness'}, {'measure': 'Acute Mountain Sickness Severity', 'timeFrame': '2 days', 'description': 'Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Altitude Sickness']}, 'referencesModule': {'references': [{'pmid': '22440488', 'type': 'RESULT', 'citation': 'Lipman GS, Kanaan NC, Holck PS, Constance BB, Gertsch JH; PAINS Group. Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories. Ann Emerg Med. 2012 Jun;59(6):484-90. doi: 10.1016/j.annemergmed.2012.01.019. Epub 2012 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude illness. Possible participants in this study are healthy adults who indicated they would like to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford University researchers hope to enroll about 100 participants.', 'detailedDescription': 'This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional arms. We will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment: The White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR).\n\nPrimary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy Male or female volunteer\n2. Age 18-65\n3. Sea-level dwelling\n4. Non pregnant\n5. Have not been to high altitude in the past week\n6. Can arrange for their own transportation to WMRS by friday evening the weekend of their study enrollment and are available the duration of the weekend of their study enrollment\n\nExclusion Criteria:\n\n1. Age \\<18 or \\>65\n2. Live at altitude \\> Sea Level +/- 1000'\n3. Pregnant\n4. Taking NSAIDs, Acetazolamide, or Corticosteroids\n5. Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past\n6. Traveled or planning to travel to high altitude in the week prior to their enrollment.\n7. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE.\n8. Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment"}, 'identificationModule': {'nctId': 'NCT01171794', 'briefTitle': 'Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)', 'orgStudyIdInfo': {'id': 'SU-12012009-4443'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ibuprofen', 'description': '600mg ibu TID', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'visually identical', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['motrin'], 'description': '3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)', 'armGroupLabels': ['ibuprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'identical number of visually identical tasteless pills as ibuprofen arm', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Grant S Lipman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Grant S Lipman', 'investigatorAffiliation': 'Stanford University'}}}}