Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01916304

Enrollment

101

Registered

2013-08-05

Start date

2013-07-31

Completion date

2014-06-30

Last updated

2015-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism

Keywords

Drug Therapy

Brief summary

The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

Detailed description

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.

Interventions

DRUGLevothyroxine sodium new formulation

Levothyroxine tablets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. (Near) total thyroidectomised patients. 2. Aged 18 years and older. 3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study. 4. Written informed consent given. 5. Able and willing to comply with protocol requirements and to complete the study.

Exclusion criteria

1. History of Graves' disease or positive TSH-receptor antibodies. 2. History of thyroid cancer requiring TSH suppression. 3. Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial. 4. Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism. 5. Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control. 6. Participation in another trial in the past 6 weeks. 7.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants That Do Not Need a Change of Dose	2 months (± 2 weeks) after switch to sodium formulation.	Dose change was determined by physician according to their clinical judgement.

Secondary

Measure	Time frame	Description
Magnitude of the Change in Daily Dose Needed	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	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	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	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.

Countries

Belgium

Participant flow

Recruitment details

Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.

Pre-assignment details

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 by arm

Arm	Count
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.	101
Total	101

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Screening failure	17

Baseline characteristics

Characteristic	Levothyroxine Sodium New Formulation
Age, Continuous	54.1 years STANDARD_DEVIATION 12.17
Age, Customized <65 years	78 participants
Age, Customized ≥ 65 years	23 participants
Calculated BMI	27.1 kg/m^2 STANDARD_DEVIATION 6
Height	168.4 cm STANDARD_DEVIATION 8.57
Investigator Reported Body Mass Index (BMI)	27.2 kg/m^2 STANDARD_DEVIATION 5.98
Region of Enrollment Belgium	101 participants
Sex: Female, Male Female	72 Participants
Sex: Female, Male Male	29 Participants
Weight	76.9 kg STANDARD_DEVIATION 18.05

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	7 / 101
serious Total, serious adverse events	7 / 101

Outcome results

Primary