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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Levothyroxine versus Levothyroxine
  • Randomized crossover study using 8 weeks of one form of levothyroxine, then 8 weeks of the other form of levothyroxine. The dose of medication does not change throughout the duration of the study.

Primary Measures

• Thyroid Stimulating Hormone Measure
  • Time Frame: 3 points over 16 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Children's Hospital Boston

Overall Clinical Trial Officials and Contacts

Rosalind S Brown, MD Principal Investigator Children's Hospital Boston  

Overall Contact: Jeremi M Carswell, MD 617-355-6168 Jeremi.Carswell@childrens.harvard.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00403390

Study ID Number: 05-11-146

ClinicalTrials.gov Identifier: NCT00403390

Health Authority: United States: Institutional Review Board