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Generic vs. Name-Brand Levothyroxine

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00403390
First received: November 21, 2006
Last updated: December 2, 2010
Last verified: December 2010
History of Changes

November 21, 2006
December 2, 2010
November 2006
December 2009   (final data collection date for primary outcome measure)
Thyroid Stimulating Hormone Measure [ Time Frame: 3 points over 16 weeks ] [ Designated as safety issue: No ]
Thyroid Stimulating Hormone Measure
Complete list of historical versions of study NCT00403390 on ClinicalTrials.gov Archive Site
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Generic vs. Name-Brand Levothyroxine
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Hypothyroidism
  • Hypothyroidism
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.
Other Names:
  • Levothyroxine (manufactured by Sandoz)
  • Synthroid (manufactured by Abbott)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
March 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
3 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00403390
05-11-146
No
Rosalind Brown, MD Clinical Trials Director, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Rosalind S Brown, MD Children's Hospital Boston
Children's Hospital Boston
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP