Clinical trial NCT01916304: Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothyroidism
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).

Primary outcomes:
measure: Percentage of Participants That Do Not Need a Change of Dose
timeFrame: 2 months (± 2 weeks) after switch to sodium formulation.
Secondary outcomes:
measure: Magnitude of the Change in Daily Dose Needed
timeFrame: 2 months (± 2 weeks) after switch to sodium formulation.
measure: Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L
timeFrame: Month 4 (± 4 weeks) after inclusion into study.
measure: Absolute Serum Thyroid Stimulating Hormone Values
timeFrame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
measure: Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
timeFrame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Other outcomes:
Locations:
city: Leuven
country: Belgium
Study officials:
affiliation: Takeda
name: Medical Responsible
role: STUDY_DIRECTOR
References: