Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
NCT ID: NCT02946918
Last Updated: 2020-12-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
14 participants
INTERVENTIONAL
2017-02-01
2019-11-04
Brief Summary
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The 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.
The 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.
Detailed Description
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The postoperative goal TSH will be between 0.1 and 0.5 mU/L (milli units per litre) in both arms.
Patients 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.
A secondary analysis will compare the dose changes required between the two groups in order to achieve goal TSH.
Another 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tablets
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine
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
Gelcaps
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine
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
Interventions
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Levothyroxine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II
* Planned total or near-total thyroidectomy
* Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
* Normal serum TSH within 12 months preceding surgery
Exclusion Criteria
* Undifferentiated, Anaplastic or Medullary Thyroid Cancer
* Planned postoperative TSH goal other than 0.1-0.5 mU/L
* History of gastrointestinal malabsorption or gastric bypass surgery
* Pregnancy
* Use of medications that alter the absorption or metabolism of levothyroxine
* Prior use of levothyroxine
18 Years
ALL
No
Sponsors
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Akrimax Pharmaceuticals
INDUSTRY
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Alex Tessnow
Associate Professor of Medicine
Principal Investigators
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Alex Tessnow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU 022015-044
Identifier Type: -
Identifier Source: org_study_id