Status:
COMPLETED
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Lead Sponsor:
Takeda
Conditions:
Hypothyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 e...
Eligibility Criteria
Inclusion
- (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
- 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).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01916304
Start Date
July 1 2013
End Date
June 1 2014
Last Update
July 20 2015
Active Locations (1)
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1
Leuven, Belgium