Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 2:06 PM
Study NCT ID:
NCT02946918
Status:
TERMINATED
Last Update Posted:
2020-12-01
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Alex.Tessnow@UTSouthwestern.edu', 'phone': '214/648-3685', 'title': 'Dr. Alex Tessnow-ASSOC PROFESSOR', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '18 weeks (until completion of the study)', 'description': 'All 14 subjects were considered at risk for adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GERD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'OG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 weeks', 'description': 'The target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Number of Dose Adjustments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'OG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'The number of dose adjustments required to attain TSH target range for each formulation will be tabulated and the data compared at the end of the study', 'unitOfMeasure': 'The number of dose adjustments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Patient Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'OG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '12.99', 'groupId': 'OG000'}, {'value': '-29.6', 'spread': '48.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,18 weeks', 'description': 'Patients will be administered survey (Thyroid-Dependent Quality of Life ) to assess their quality of life (at the beginning of the study and again at study completion). The results of these scores will be tabulated and compared between the two arms. Possible score range from 0 to 450; lower score means improved quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'OG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '39', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'FG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Patient unblinded himself', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Ran out of study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'id': 'BG001', 'title': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)\n\nLevothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps'}, {'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': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-16', 'size': 603124, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-02T20:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Terminating study as sponsor has sold the drug to another company', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2016-10-21', 'resultsFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-04', 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks', 'timeFrame': '18 weeks', 'description': 'The target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Dose Adjustments', 'timeFrame': '18 weeks', 'description': 'The number of dose adjustments required to attain TSH target range for each formulation will be tabulated and the data compared at the end of the study'}, {'measure': 'Change in Mean Patient Quality of Life Score', 'timeFrame': 'Baseline,18 weeks', 'description': 'Patients will be administered survey (Thyroid-Dependent Quality of Life ) to assess their quality of life (at the beginning of the study and again at study completion). The results of these scores will be tabulated and compared between the two arms. Possible score range from 0 to 450; lower score means improved quality of life.'}, {'measure': 'Treatment Satisfaction Survey', 'timeFrame': '18 weeks', 'description': 'The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levothyroxine'], 'conditions': ['Thyroid Cancer', 'Postsurgical Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '24896369', 'type': 'BACKGROUND', 'citation': 'Vita R, Fallahi P, Antonelli A, Benvenga S. The administration of L-thyroxine as soft gel capsule or liquid solution. Expert Opin Drug Deliv. 2014 Jul;11(7):1103-11. doi: 10.1517/17425247.2014.918101. Epub 2014 Jun 4.'}, {'pmid': '15671770', 'type': 'BACKGROUND', 'citation': 'McMillan CV, Bradley C, Woodcock A, Razvi S, Weaver JU. Design of new questionnaires to measure quality of life and treatment satisfaction in hypothyroidism. Thyroid. 2004 Nov;14(11):916-25. doi: 10.1089/thy.2004.14.916.'}]}, 'descriptionModule': {'briefSummary': 'In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and more unpredictable TSH (thyroid stimulating hormone) levels.\n\nThe investigators therefore hypothesize that following thyroidectomy for Stage I/II differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone levels in the postoperative period.\n\nThe aim of this investigation is to compare the use of levothyroxine in liquid gel capsules to tablet form for TSH suppression following thyroidectomy for presumed stage I/II differentiated thyroid cancer.', 'detailedDescription': "Ten patients will be randomized prior to surgery to receive levothyroxine in tablet form and ten patients will be randomized to receive in gel capsule form. Both forms will be encapsulated in order to allow double-blinding of the study.\n\nThe postoperative goal TSH will be between 0.1 and 0.5 mU/L (milli units per litre) in both arms.\n\nPatients will be seen at weeks 6, 12 and 18 postoperatively and have TSH and Free T4 measured. The primary outcome is the number of patients at each visit that are at goal range TSH.\n\nA secondary analysis will compare the dose changes required between the two groups in order to achieve goal TSH.\n\nAnother secondary analysis will investigate the patients' quality of life. Two different surveys (see secondary outcomes below) will be performed at both study entry and completion to compare the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II\n* Planned total or near-total thyroidectomy\n* Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively\n* Normal serum TSH within 12 months preceding surgery\n\nExclusion Criteria:\n\n* AJCC Stage III or greater\n* Undifferentiated, Anaplastic or Medullary Thyroid Cancer\n* Planned postoperative TSH goal other than 0.1-0.5 mU/L\n* History of gastrointestinal malabsorption or gastric bypass surgery\n* Pregnancy\n* Use of medications that alter the absorption or metabolism of levothyroxine\n* Prior use of levothyroxine'}, 'identificationModule': {'nctId': 'NCT02946918', 'briefTitle': 'Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients', 'orgStudyIdInfo': {'id': 'STU 022015-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tablets', 'description': 'Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)', 'interventionNames': ['Drug: Levothyroxine']}, {'type': 'EXPERIMENTAL', 'label': 'Gelcaps', 'description': 'Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)', 'interventionNames': ['Drug: Levothyroxine']}], 'interventions': [{'name': 'Levothyroxine', 'type': 'DRUG', 'otherNames': ['Tirosint, Synthroid'], 'description': 'Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily', 'armGroupLabels': ['Gelcaps', 'Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alex Tessnow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Akrimax Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Alex Tessnow', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}