Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT01265056
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2010-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Neurontin on Pain Management in the Acutely Burned Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'jennifer-lassner@uiowa.edu', 'phone': '319-335-2123', 'title': 'Jennifer Lassner', 'organization': 'The University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sugar Pill', 'description': 'Patients in this group received a sugar pill which looked identical to gabapentin.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gabapentin', 'description': 'Patients in this group received gabapentin which looked just like the sugar pill.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received a sugar pill similar to gabapentin.'}, {'id': 'OG001', 'title': 'Gabapentin', 'description': 'Patients received gabapentin.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From time of enrollment to 2 weeks after being discharged', 'unitOfMeasure': 'morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.'}, {'type': 'SECONDARY', 'title': 'Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received a sugar pill similar to gabapentin.'}, {'id': 'OG001', 'title': 'Gabapentin', 'description': 'Patients received gabapentin.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.8', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'First Clinic Follow Up After Discharge', 'description': 'The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received a sugar pill similar to gabapentin.'}, {'id': 'OG001', 'title': 'Gabapentin', 'description': 'Patients received gabapentin.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'First Clinic Follow Up After Discharge', 'description': 'The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugar Pill', 'description': 'Patients in this group received a sugar pill which looked identical to gabapentin.'}, {'id': 'FG001', 'title': 'Gabapentin', 'description': 'Patients in this group received gabapentin which looked just like the sugar pill.'}], 'periods': [{'title': 'Initial Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment period 1/2010 to 9/13/2011. Patients were recruited for the study if they met criteria and were admitted for burn injuries.', 'preAssignmentDetails': 'There were no significant events or approaches following enrollment. Patients were randomized into groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugar Pill', 'description': 'Patients in this group received a sugar pill which looked identical to gabapentin.'}, {'id': 'BG001', 'title': 'Gabapentin', 'description': 'Patients in this group received gabapentin which looked just like the sugar pill.'}, {'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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participant, Care Provider and Investigator are all masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2010-12-20', 'resultsFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-01-22', 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)', 'timeFrame': 'From time of enrollment to 2 weeks after being discharged'}], 'secondaryOutcomes': [{'measure': 'Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups', 'timeFrame': 'First Clinic Follow Up After Discharge', 'description': 'The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.'}, {'measure': 'Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)', 'timeFrame': 'First Clinic Follow Up After Discharge', 'description': 'The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Burn Injury']}, 'referencesModule': {'references': [{'pmid': '16819344', 'type': 'BACKGROUND', 'citation': 'Gibran NS; Committee on Organization and Delivery of Burn Care, American Burn Association. Practice Guidelines for burn care, 2006. J Burn Care Res. 2006 Jul-Aug;27(4):437-8. doi: 10.1097/01.BCR.0000226084.26680.56. No abstract available.'}, {'pmid': '17071002', 'type': 'BACKGROUND', 'citation': 'Cuignet O, Pirson J, Soudon O, Zizi M. Effects of gabapentin on morphine consumption and pain in severely burned patients. Burns. 2007 Feb;33(1):81-6. doi: 10.1016/j.burns.2006.04.020. Epub 2006 Oct 30.'}, {'pmid': '17434800', 'type': 'BACKGROUND', 'citation': 'Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain. 2007 Jul;8(7):533-48. doi: 10.1016/j.jpain.2007.02.426. Epub 2007 Apr 16.'}, {'pmid': '14982565', 'type': 'BACKGROUND', 'citation': 'Dierking G, Duedahl TH, Rasmussen ML, Fomsgaard JS, Moiniche S, Romsing J, Dahl JB. Effects of gabapentin on postoperative morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):322-7. doi: 10.1111/j.0001-5172.2004.0329.x.'}, {'pmid': '18366516', 'type': 'BACKGROUND', 'citation': 'Gray P, Williams B, Cramond T. Successful use of gabapentin in acute pain management following burn injury: a case series. Pain Med. 2008 Apr;9(3):371-6. doi: 10.1111/j.1526-4637.2006.00149.x.'}, {'pmid': '12441827', 'type': 'BACKGROUND', 'citation': 'Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain. 2002 Nov-Dec;18(6):343-9. doi: 10.1097/00002508-200211000-00001.'}, {'pmid': '17920770', 'type': 'BACKGROUND', 'citation': "Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice ASC, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-251. doi: 10.1016/j.pain.2007.08.033. Epub 2007 Oct 24."}]}, 'descriptionModule': {'briefSummary': 'Burn patients have extreme pain. Opioids are the main agents used for analgesia. We therefore propose a single center study to fruther assess the efficacy of neuropathic agents in controlling the pain associated with acute thermal injury.', 'detailedDescription': "The study was conducted in a 16-bed American Burn Association certified burn unit. Patients age \\>18 years old, with at least a 5% burn injury and an expected length of stay (LOS) of 48 hours, were approached for enrollment in this prospective, placebo controlled randomized study. Patients who were pregnant, lactating, prisoners or who had renal insufficiency were excluded. After consent, patients were assigned to either placebo or Gp by random numbers generated in Microsoft Excel (2010). Both the drug and the placebo were over-encapsulated to appear identical. The placebo pills contained starch. The research clinical pharmacist was the only unblinded staff member and did not participate in clinical care of the patients.\n\nFollowing randomization, patients received a loading dose of study drug on day one and began three times a day (TID) dosing per the dose escalation schedule the following day. At discharge, patients were given a three day taper per the dose de-escalation schedule Patients were assessed for completion of psychosocial adjustment (Brief Symptom Inventory, BSI, and Sickness Inventory Profile, SIP) at their first clinic visit.\n\nAgents used for pain control included: acetaminophen, non-steroidal anti-inflammatories, morphine instantaneous release and morphine extended release. In the case of allergies or ineffectiveness, other agents were occasionally used. Short acting morphine was ordered every two hours prn and hydromorphone was ordered every four hours as needed. All were converted to morphine equivalents.\n\nThe study was powered to detect a 22% difference in opioid consumption between the two groups based on the work by Cuignet et al. It was estimated that a total of 50 patients were needed to achieve an alpha of 0.05 and a beta of 0.80 to detect the difference in the primary endpoint.\n\nFor statistical purposes, conversion tables were used to convert all opioid medications into morphine equivalents with 1 morphine equivalents (ME)=30mg oral morphine. The primary outcome variable (morphine consumption) were adjusted for days past injury. The BSI and SIP scales were scored according to study directions.\n\nBoth an intention to treat and actual treatment analysis were performed using Stata 11.2 for Windows (Stata Corp. College Station, Texas, U.S.A.). Continuous variables between groups were analyzed with the students T test. Categorical variables were analyzed with the Chi Square test or Fischer Exact Test where appropriate. A random effects model adjusting for confounders was used to assess the effect of treatment on the outcome measures. The study was approved by the University's Institutional Review Board and was registered with the clinical trials association (200909736)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All admitted patients with LOS expected to be \\> 48 hours (usually burn injury \\> 5%)\n* \\> 18 years of age\n* Thermal injury to skin\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant or nursing women\n* Children \\<18 years of age\n* Frostbite or non thermal injury to skin\n* Renal insuffiency (creatinine clearance \\< 60mL/min) or failure (on renal replacement)\n* Expected length of stay \\< 48 hours (this usually includes burn \\<5%'}, 'identificationModule': {'nctId': 'NCT01265056', 'briefTitle': 'The Effect of Neurontin on Pain Management in the Acutely Burned Patient', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'The Effect of Neurontin on Pain Management in the Acutely Burned Patient', 'orgStudyIdInfo': {'id': '200909736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': 'Gabapentin', 'interventionNames': ['Drug: Gabapentin']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'On Study day 1: 1200mg (single dose).\n\nStudy day 2,3: 300mg TID, 900mg daily.\n\nStudy day 4-7: 600mg TID 1800mg\\* daily.\n\nStudy day 8-11: 800mg TID 2400mg\\* daily \\[Optional increase to 2400 if pain scores are still 4 on NRS\\]\n\nStudy day 11: 1200mg TID 3600mg\\* daily \\[Optional increase to 3600 if pain scores are still \\>4 on NRS\\]\n\n\\* May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation.', 'armGroupLabels': ['Gabapentin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar Pill is administered similar to the protocol used for the investigational drug.', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52241', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Burn Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Lucy Wibbenmeyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data is available', 'ipdSharing': 'YES', 'description': 'Researchers can contact me (lucy-wibbenmeyer@uiowa.edu) for study protocol or statistical plan.', 'accessCriteria': 'Email permission. Deidentified information only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lucy A Wibbenmeyer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Lucy A Wibbenmeyer', 'investigatorAffiliation': 'University of Iowa'}}}}