Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

NCT02946918 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STU 022015-044
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Postsurgical Hypothyroidism

Keywords

levothyroxine

Outcome Measures

Primary Outcomes (1)

• Number of Patients in Each Group at Predefined Target TSH Range at 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.

  18 weeks

Secondary Outcomes (3)

• Mean Number of Dose Adjustments

  18 weeks

• Change in Mean Patient Quality of Life Score

  Baseline,18 weeks

• Treatment Satisfaction Survey

  18 weeks

Study Arms (2)

Tablets

EXPERIMENTAL

Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)

Drug: Levothyroxine

Gelcaps

EXPERIMENTAL

Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

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

Also known as: Tirosint, Synthroid

Gelcaps; Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Akrimax Pharmaceuticals: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

• 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: 24896369 BACKGROUND

• 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.

  PMID: 15671770 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Alex Tessnow-ASSOC PROFESSOR
• Organization: UT Southwestern Medical Center

Alex.Tessnow@UTSouthwestern.edu

214/648-3685

Study Officials

• Alex Tessnow, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 27, 2016
• Study Start: February 1, 2017
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)