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

NCT ID: NCT01916304

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Levothyroxine sodium new formulation

Intervention Type: DRUG

Levothyroxine tablets

Interventions

Levothyroxine sodium new formulation

Levothyroxine tablets

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Takeda

Locations

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2012-005732-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1145-3526

Identifier Type: REGISTRY

Identifier Source: secondary_id

LE-9999-401-BE

Identifier Type: -

Identifier Source: org_study_id