Generic vs. Name-Brand Levothyroxine
Information source: Children's Hospital Boston
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Hypothyroidism; Hypothyroidism
Intervention: Levothyroxine versus Levothyroxine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Children's Hospital Boston Official(s) and/or principal investigator(s):
Rosalind S Brown, MD, Principal Investigator, Affiliation: Children's Hospital Boston
Overall contact:
Jeremi M Carswell, MD, Phone: 617-355-6168, Email: Jeremi.Carswell@childrens.harvard.edu
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.
Clinical Details
Official title: Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Thyroid Stimulating Hormone Measure
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jeremi M Carswell, MD, Phone: 617-355-6168, Email: Jeremi.Carswell@childrens.harvard.edu
Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting
Additional Information
Starting date: June 2006
Ending date: March 2009
Last updated: May 9, 2008
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