A Phase 2 interventional study of Levothyroxine sodium new formulation in Hypothyroidism, sponsored by Takeda. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-20.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
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.
247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's enrollment of 101 is above the median of 78 across 128 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Levothyroxine tablets
Percentage of Participants That Do Not Need a Change of Dose
Dose change was determined by physician according to their clinical judgement.
Time frame: 2 months (± 2 weeks) after switch to sodium formulation.
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.
Time frame: 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
Blood samples were collected and samples were analyzed according to the local Quality System.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.
| Milestone | Levothyroxine Sodium New Formulation |
|---|---|
| Started | 101 |
| Safety set | 101 |
| Intent-to-treat set | 84 |
| Completed | 84 |
| Not completed | 17 |
| Withdrew: Screening failure | 17 |
Dose change was determined by physician according to their clinical judgement.
| percentage of participants | Levothyroxine Sodium New Formulation |
|---|---|
| Percentage of Participants That Do Not Need a Change of Dose | 32.9 (23.7 to 43.7) |
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 | Levothyroxine Sodium New Formulation |
|---|---|
| -25 μg change | 19.51 |
| -12.5 μg change | 42.68 |
| -6.25 μg change | 1.22 |
| -5.35 μg change | 1.22 |
| 0 μg change | 32.93 |
| +12.5 μg change | 2.44 |
Blood samples were collected and samples were analyzed according to the local Quality System.
| percentage of participants | Levothyroxine Sodium New Formulation |
|---|---|
| Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | 57.3 |
Blood samples were collected and samples were analyzed according to the local Quality System.
| mIU/mL | Levothyroxine Sodium New Formulation |
|---|---|
| Baseline | 1.1 ± 0.59 |
| Month 2 (n=83) | 0.3 ± 1.69 |
| Month 4 (n=82) | 0.6 ± 1.09 |
Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
| percent change | Levothyroxine Sodium New Formulation |
|---|---|
| Month 2 | -74.5 ± 192.14 |
| Month 4 (n=82) | -54.0 ± 173.36 |
Collected over 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levothyroxine Sodium New Formulation | — | 7/101 (6.9%) | 7/101 (6.9%) |
| Event | Levothyroxine Sodium New Formulation |
|---|---|
| Cardiac failureCardiac disorders | 1/101 |
| Post procedural haematomaInjury, poisoning and procedural complications | 1/101 |
| Catheterisation cardiacInvestigations | 1/101 |
| Skin lesionSkin and subcutaneous tissue disorders | 1/101 |
| Bladder catheterisationSurgical and medical procedures | 1/101 |
| HysterectomySurgical and medical procedures | 1/101 |
| MastectomySurgical and medical procedures | 1/101 |
| Salivary gland resectionSurgical and medical procedures | 1/101 |
| HaemorrhageVascular disorders | 1/101 |
| Event | Levothyroxine Sodium New Formulation |
|---|---|
| NasopharyngitisInfections and infestations | 7/101 |
| Age, Continuous(years) | Levothyroxine Sodium New Formulation |
|---|---|
| Mean | 54.1 ± 12.17 |
| Age, Customized(participants) | Levothyroxine Sodium New Formulation |
|---|---|
| <65 years | 78 |
| ≥ 65 years | 23 |
| Sex: Female, Male(Participants) | Levothyroxine Sodium New Formulation |
|---|---|
| Female | 72 |
| Male | 29 |
| Region of Enrollment(participants) | Levothyroxine Sodium New Formulation |
|---|---|
| Belgium | 101 |
| Weight(kg) | Levothyroxine Sodium New Formulation |
|---|---|
| Mean | 76.9 ± 18.05 |
| Height(cm) | Levothyroxine Sodium New Formulation |
|---|---|
| Mean | 168.4 ± 8.57 |
| Investigator Reported Body Mass Index (BMI)(kg/m^2) | Levothyroxine Sodium New Formulation |
|---|---|
| Mean | 27.2 ± 5.98 |
| Calculated BMI(kg/m^2) | Levothyroxine Sodium New Formulation |
|---|---|
| Mean | 27.1 ± 6.00 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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