Generic vs. Name-Brand Levothyroxine - Full Text View

Sponsor:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00403390

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 III

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

Resource links provided by NLM:

Genetics Home Reference related topics: congenital hypothyroidism pseudoachondroplasia

MedlinePlus related topics: Thyroid Diseases

Drug Information available for: Thyroxine Levothyroxine Sodium Levothroid

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

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)

Intervention Details:

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)

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

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403390

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Investigators

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 February 13, 2012