NCT00403390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
8 years until next milestone

Results Posted

Study results publicly available

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

November 21, 2006

Results QC Date

January 20, 2017

Last Update Submit

January 24, 2018

Conditions

Congenital HypothyroidismHypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.

    3 points over 16 weeks

Study Arms (2)

Brand name levothyroxine (Synthroid)

EXPERIMENTAL

Dose previously demonstrated to normalize thyroid function given daily for 2 months

Drug: Brand Name Levothyroxine (Synthroid)

Generic formulation of Levothyroxine

ACTIVE COMPARATOR

Dosage previously determined to normalize thyroid function given daily for 2 months

Drug: Generic formulation of Levothyroxine

Interventions

Brand Name Levothyroxine (Synthroid)DRUG

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.

Also known as: Levothyroxine
Brand name levothyroxine (Synthroid)
Generic formulation of LevothyroxineDRUG

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.

Also known as: No other names
Generic formulation of Levothyroxine

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 3 and 18 years
  • Diagnosis of Congenital Hypothyroidism with initial TSH \> 100
  • Ability to understand directions and follow all instructions

You may not qualify if:

  • Not on any drug interfering with absorption of levothyroxine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Carswell JM, Gordon JH, Popovsky E, Hale A, Brown RS. Generic and brand-name L-thyroxine are not bioequivalent for children with severe congenital hypothyroidism. J Clin Endocrinol Metab. 2013 Feb;98(2):610-7. doi: 10.1210/jc.2012-3125. Epub 2012 Dec 21.

    PMID: 23264396RESULT

MeSH Terms

Conditions

Congenital HypothyroidismHypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Limitations and Caveats

Proof of principle study; small sample. Results may not be applicable to all populations.

Results Point of Contact

Title
Jeremi Carswell, MD
Organization
Children's Hospital Boston
Jeremi.Carswell@childrens.harvard.edu
617-355-7476

Study Officials

  • Rosalind S Brown, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

February 23, 2018

Results First Posted

February 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Nothing currently planned

Locations

US(1)