NCT01916304

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Levothyroxine sodium new formulation	Levothyroxine tablets

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-08-05
• Last updated: 2015-07-20
• Results posted: 2015-07-20

Locations

1 site across 1 country: Belgium