Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-30 @ 7:04 AM
Study NCT ID:
NCT01916304
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "5 months from inclusion (all patients) or up to recovery/final status is known for AE's.", 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.', 'otherNumAtRisk': 101, 'otherNumAffected': 7, 'seriousNumAtRisk': 101, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bladder catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Salivary gland resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants That Do Not Need a Change of Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '43.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months (± 2 weeks) after switch to sodium formulation.', 'description': 'Dose change was determined by physician according to their clinical judgement.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Magnitude of the Change in Daily Dose Needed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'classes': [{'title': '-25 μg change', 'categories': [{'measurements': [{'value': '19.51', 'groupId': 'OG000'}]}]}, {'title': '-12.5 μg change', 'categories': [{'measurements': [{'value': '42.68', 'groupId': 'OG000'}]}]}, {'title': '-6.25 μg change', 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000'}]}]}, {'title': '-5.35 μg change', 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000'}]}]}, {'title': '0 μg change', 'categories': [{'measurements': [{'value': '32.93', 'groupId': 'OG000'}]}]}, {'title': '+12.5 μg change', 'categories': [{'measurements': [{'value': '2.44', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months (± 2 weeks) after switch to sodium formulation.', 'description': 'Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Serum Thyroid Stimulating Hormone Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.6'}]}]}, {'title': 'Month 2 (n=83)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.69', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}]}]}, {'title': 'Month 4 (n=82)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'classes': [{'title': 'Month 2', 'categories': [{'measurements': [{'value': '-74.5', 'spread': '192.14', 'groupId': 'OG000', 'lowerLimit': '-89.5', 'upperLimit': '-50.6'}]}]}, {'title': 'Month 4 (n=82)', 'categories': [{'measurements': [{'value': '-54.0', 'spread': '173.36', 'groupId': 'OG000', 'lowerLimit': '-75.1', 'upperLimit': '-15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, with data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Intent-to-Treat Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.', 'preAssignmentDetails': 'Participants with a diagnosis of Primary Hypothyroidism were switched from treatment with L-Thyroxine Christiaens® to treatment with new levothyroxine sodium 25-225 μg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Levothyroxine Sodium New Formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '12.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'spread': '18.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Weight data is available for 100 participants.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.4', 'spread': '8.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Height data was available for 96 participants.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Investigator Reported Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Investigator reported BMI data was available for 93 participants.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calculated BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'spread': '6.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated BMI data was available for 96 participants.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2013-08-01', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2013-08-01', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-22', 'studyFirstPostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants That Do Not Need a Change of Dose', 'timeFrame': '2 months (± 2 weeks) after switch to sodium formulation.', 'description': 'Dose change was determined by physician according to their clinical judgement.'}], 'secondaryOutcomes': [{'measure': 'Magnitude of the Change in Daily Dose Needed', 'timeFrame': '2 months (± 2 weeks) after switch to sodium formulation.', 'description': 'Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.'}, {'measure': 'Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L', 'timeFrame': 'Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System.'}, {'measure': 'Absolute Serum Thyroid Stimulating Hormone Values', 'timeFrame': 'Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System.'}, {'measure': 'Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone', 'timeFrame': 'Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.', 'description': 'Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.', 'detailedDescription': 'The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.\n\nThe results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.\n\nThe study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).\n\nAll participants will be asked to take a daily dose at the same time each day throughout the study.\n\nThis study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. (Near) total thyroidectomised patients.\n2. Aged 18 years and older.\n3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.\n4. Written informed consent given.\n5. Able and willing to comply with protocol requirements and to complete the study.\n\nExclusion Criteria:\n\n1. History of Graves' disease or positive TSH-receptor antibodies.\n2. History of thyroid cancer requiring TSH suppression.\n3. Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.\n4. Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.\n5. Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.\n6. Participation in another trial in the past 6 weeks.\n7. Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch)."}, 'identificationModule': {'nctId': 'NCT01916304', 'briefTitle': 'Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicentre, Open-label Switch Study to Investigate the Necessity of Dose Adjustment After Switching From L-Thyroxine Christiaens® to the New Levothyroxine Sodium Test Formulation in (Near) Total Thyroidectomised Patients.', 'orgStudyIdInfo': {'id': 'LE-9999-401-BE'}, 'secondaryIdInfos': [{'id': '2012-005732-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1145-3526', 'type': 'REGISTRY', 'domain': 'UTN (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levothyroxine sodium new formulation', 'description': 'Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.', 'interventionNames': ['Drug: Levothyroxine sodium new formulation']}], 'interventions': [{'name': 'Levothyroxine sodium new formulation', 'type': 'DRUG', 'description': 'Levothyroxine tablets', 'armGroupLabels': ['Levothyroxine sodium new formulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}