Hypothyroidism | Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Hypothyroidism research study
What is the primary objective of this study?
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
Who is eligible to participate?
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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Levothyroxine sodium new formulationLevothyroxine tablets
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Levothyroxine sodium new formulationLevothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
Start Date: July 2013
Completed Date: June 2014
Phase: Phase 2
Primary Outcome: Percentage of Participants That Do Not Need a Change of Dose
Secondary Outcome: Magnitude of the Change in Daily Dose Needed
Study sponsors, principal investigator, and references
Principal Investigator: Medical Responsible
Lead Sponsor: Takeda