NCT00403390

Generic vs. Name-Brand Levothyroxine

Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Congenital Hypothyroidism
• Hypothyroidism

Interventions

Type	Name	Description
DRUG	Brand Name Levothyroxine (Synthroid)	Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.
DRUG	Generic formulation of Levothyroxine	Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2006-11-23
• Last updated: 2018-02-23
• Results posted: 2018-02-23

Locations

1 site across 1 country: United States