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

Phase 2

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: Levothyroxine sodium new formulation

• Registration Number: NCT01916304
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Results First Posted: 2015-07-20
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levothyroxine sodium new formulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.