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.

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

Study Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Drug: Levothyroxine sodium new 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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Levothyroxine sodium new formulation; Levothyroxine tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months (± 2 weeks) after switch to sodium formulation.
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.	Month 4 (± 4 weeks) after inclusion into study.
Absolute Serum Thyroid Stimulating Hormone Values	Blood samples were collected and samples were analyzed according to the local Quality System.	Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
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.	Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Responsible, Takeda

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: LE-9999-401-BE; 2012-005732-28 (EudraCT Number); U1111-1145-3526 (Registry Identifier: UTN (WHO))