Generic vs. Name-Brand Levothyroxine
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism |
- Thyroid Stimulating Hormone Measure [ Time Frame: 3 points over 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | November 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
-
Drug: Levothyroxine versus Levothyroxine
- Levothyroxine (manufactured by Sandoz)
- Synthroid (manufactured by Abbott)
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.
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age between 3 and 18 years
- Diagnosis of Congenital Hypothyroidism with initial TSH > 100
- Ability to understand directions and follow all instructions
Exclusion Criteria:
- Not on any drug interfering with absorption of levothyroxine
Contacts and Locations| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Rosalind S Brown, MD | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Rosalind Brown, MD Clinical Trials Director, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00403390 History of Changes |
| Other Study ID Numbers: | 05-11-146 |
| Study First Received: | November 21, 2006 |
| Last Updated: | December 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Congenital Hypothyroidism Hypothyroidism Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Bone Diseases, Endocrine Genetic Diseases, Inborn Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on May 22, 2013