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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005732-28 | EudraCT Number | ||
| U1111-1145-3526 | Registry Identifier | UTN (WHO) |
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The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
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.
The 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.
The 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).
All participants will be asked to take a daily dose at the same time each day throughout the study.
This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine sodium new formulation | Experimental | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine sodium new formulation | Drug | Levothyroxine tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Do Not Need a Change of Dose | Dose change was determined by physician according to their clinical judgement. | 2 months (± 2 weeks) after switch to sodium formulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of the Change in Daily Dose Needed | 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. | 2 months (± 2 weeks) after switch to sodium formulation. |
| Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven | Belgium |
Participants with a diagnosis of Primary Hypothyroidism were switched from treatment with L-Thyroxine Christiaens® to treatment with new levothyroxine sodium 25-225 μg.
Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levothyroxine Sodium New Formulation | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levothyroxine Sodium New Formulation | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants That Do Not Need a Change of Dose | Dose change was determined by physician according to their clinical judgement. | Participants from the intent-to-treat population, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 months (± 2 weeks) after switch to sodium formulation. |
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5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
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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 | Levothyroxine Sodium New Formulation | Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Blood samples were collected and samples were analyzed according to the local Quality System. |
| Month 4 (± 4 weeks) after inclusion into study. |
| Absolute Serum Thyroid Stimulating Hormone Values | Blood samples were collected and samples were analyzed according to the local Quality System. | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. |
| Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone | Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement. | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Weight | Weight data is available for 100 participants. | Mean | Standard Deviation | kg |
|
| Height | Height data was available for 96 participants. | Mean | Standard Deviation | cm |
|
| Investigator Reported Body Mass Index (BMI) | Investigator reported BMI data was available for 93 participants. | Mean | Standard Deviation | kg/m^2 |
|
| Calculated BMI | Calculated BMI data was available for 96 participants. | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Magnitude of the Change in Daily Dose Needed | 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. | Participants from the intent-to-treat population, with data available for analysis. | Posted | Number | percentage of participants | 2 months (± 2 weeks) after switch to sodium formulation. |
|
|
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| Secondary | Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | Blood samples were collected and samples were analyzed according to the local Quality System. | Participants from the intent-to-treat population, with data available for analysis. | Posted | Number | percentage of participants | Month 4 (± 4 weeks) after inclusion into study. |
|
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| Secondary | Absolute Serum Thyroid Stimulating Hormone Values | Blood samples were collected and samples were analyzed according to the local Quality System. | Participants from the intent-to-treat population, with data available for analysis. | Posted | Mean | Inter-Quartile Range | mIU/mL | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. |
|
|
|
| Secondary | Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone | Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement. | Participants from the intent-to-treat population, with data available for analysis. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. |
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|
|
| 7 |
| 101 |
| 7 |
| 101 |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Catheterisation cardiac | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Bladder catheterisation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Mastectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Salivary gland resection | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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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.
| Title | Measurements |
|---|---|
|
| -5.35 μg change |
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| 0 μg change |
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| +12.5 μg change |
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