Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre, Open-label Switch Study to Investigate the Necessity of Dose Adjustment After Switching From L-Thyroxine Christiaens® to the New Levothyroxine Sodium Test Formulation in (Near) Total Thyroidectomised Patients.|
- Percentage of Participants That Do Not Need a Change of Dose [ Time Frame: 2 months (± 2 weeks) after switch to sodium formulation. ]Dose change was determined by physician according to their clinical judgement.
- Magnitude of the Change in Daily Dose Needed [ Time Frame: 2 months (± 2 weeks) after switch to sodium formulation. ]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.
- Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L [ Time Frame: Month 4 (± 4 weeks) after inclusion into study. ]Blood samples were collected and samples were analyzed according to the local Quality System.
- Absolute Serum Thyroid Stimulating Hormone Values [ Time Frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. ]Blood samples were collected and samples were analyzed according to the local Quality System.
- Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone [ Time Frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. ]Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
|Study Start Date:||July 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Levothyroxine sodium new 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916304
|Study Director:||Medical Responsible||Takeda|