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Sponsored by: |
Children's Hospital Boston |
Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00403390 |
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.
Condition | Intervention | Phase |
Congenital Hypothyroidism Hypothyroidism |
Drug: Levothyroxine versus Levothyroxine |
Phase III |
Genetics Home Reference related topics: | congenital hypothyroidism pseudoachondroplasia |
ChemIDplus related topics: | Levothyroxine Sodium Thyroxine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism |
Estimated Enrollment: | 40 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.
Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeremi M Carswell, MD | 617-355-6168 | Jeremi.Carswell@childrens.harvard.edu |
United States, Massachusetts | |||||
Children's Hospital Boston | Recruiting | ||||
Boston, Massachusetts, United States, 02115 |
Children's Hospital Boston |
Principal Investigator: | Rosalind S Brown, MD | Children's Hospital Boston |
Responsible Party: | Children's Hospital Boston ( Rosalind Brown, MD Clinical Trials Director ) |
Study ID Numbers: | 05-11-146 |
First Received: | November 21, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00403390 |
Health Authority: | United States: Institutional Review Board |
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