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Terminating study as sponsor has sold the drug to another company
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| Name | Class |
|---|---|
| Akrimax Pharmaceuticals | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablets | Experimental | Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes) |
|
| Gelcaps | Experimental | Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Dose Adjustments | 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 | 18 weeks |
| Change in Mean Patient Quality of Life Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Tessnow, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24896369 | Background | 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. | |
| 15671770 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Gelcaps |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 18 weeks |
|
18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GERD | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alex Tessnow-ASSOC PROFESSOR | UT Southwestern Medical Center | 214/648-3685 | Alex.Tessnow@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2018 | Oct 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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|
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.
| Baseline,18 weeks |
| Treatment Satisfaction Survey | The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient) | 18 weeks |
| Ran out of study medication |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Mean Number of Dose Adjustments | 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 | Posted | Mean | Standard Deviation | The number of dose adjustments | 18 weeks |
|
|
|
| Secondary | Change in Mean Patient Quality of Life Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline,18 weeks |
|
|
|
| Secondary | Treatment Satisfaction Survey | The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient) | 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. | Posted | Mean | Standard Deviation | score on a scale | 18 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 3 | 8 |
| anxiety | Nervous system disorders | Systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | Endocrine disorders | Systematic Assessment |
|
| hypocalcemia | Endocrine disorders | Systematic Assessment |
|
| rosacea | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |