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Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946918
Recruitment Status : Terminated (Terminating study as sponsor has sold the drug to another company)
First Posted : October 27, 2016
Results First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
Akrimax Pharmaceuticals
Information provided by (Responsible Party):
Alex Tessnow, University of Texas Southwestern Medical Center

Brief Summary:

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.

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.


Condition or disease Intervention/treatment Phase
Thyroid Cancer Postsurgical Hypothyroidism Drug: Levothyroxine Phase 4

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tablets
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Drug: 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 Name: Tirosint, Synthroid

Experimental: Gelcaps
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Drug: 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 Name: Tirosint, Synthroid




Primary Outcome Measures :
  1. Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks [ Time Frame: 18 weeks ]
    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.


Secondary Outcome Measures :
  1. Mean Number of Dose Adjustments [ Time Frame: 18 weeks ]
    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

  2. Change in Mean Patient Quality of Life Score [ Time Frame: Baseline,18 weeks ]
    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.

  3. Treatment Satisfaction Survey [ Time Frame: 18 weeks ]
    The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • 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:

  • AJCC Stage III or greater
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946918


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Akrimax Pharmaceuticals
Investigators
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Principal Investigator: Alex Tessnow, MD University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Alex Tessnow, University of Texas Southwestern Medical Center:
Publications:
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Responsible Party: Alex Tessnow, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02946918    
Other Study ID Numbers: STU 022015-044
First Posted: October 27, 2016    Key Record Dates
Results First Posted: December 1, 2020
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alex Tessnow, University of Texas Southwestern Medical Center:
levothyroxine
Additional relevant MeSH terms:
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Thyroid Neoplasms
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms