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

Primary Purpose

Hypothyroidism

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Levothyroxine sodium new formulation

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levothyroxine sodium new formulation

Arm Description

Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.

Outcomes

Primary Outcome Measures

Percentage of Participants That Do Not Need a Change of Dose

Dose change was determined by physician according to their clinical judgement.

Secondary Outcome Measures

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.

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.

Absolute Serum Thyroid Stimulating Hormone Values

Blood samples were collected and samples were analyzed according to the local Quality System.

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.

Full Information

NCT ID

NCT01916304

First Posted

August 1, 2013

Last Updated

June 22, 2015

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT01916304

Brief Title

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

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothyroidism

Keywords

Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levothyroxine sodium new formulation

Arm Type

Experimental

Arm Description

Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.

Intervention Type

Drug

Intervention Name(s)

Levothyroxine sodium new formulation

Intervention Description

Levothyroxine tablets

Primary Outcome Measure Information:

Title

Percentage of Participants That Do Not Need a Change of Dose

Description

Dose change was determined by physician according to their clinical judgement.

Time Frame

2 months (± 2 weeks) after switch to sodium formulation.

Secondary Outcome Measure Information:

Title

Magnitude of the Change in Daily Dose Needed

Description

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.

Title

Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L

Description

Blood samples were collected and samples were analyzed according to the local Quality System.

Time Frame

Month 4 (± 4 weeks) after inclusion into study.

Title

Absolute Serum Thyroid Stimulating Hormone Values

Description

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.

Title

Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (Near) total thyroidectomised patients. Aged 18 years and older. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study. Written informed consent given. Able and willing to comply with protocol requirements and to complete the study. Exclusion Criteria: History of Graves' disease or positive TSH-receptor antibodies. History of thyroid cancer requiring TSH suppression. Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial. Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism. Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control. Participation in another trial in the past 6 weeks. 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Leuven

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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