N/A
N=34
Generic vs. Name-Brand Levothyroxine
Congenital Hypothyroidism · Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00403390 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: 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. — 2.455; 2.131; 0.788; 3.053 uIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brand Name Levothyroxine (Synthroid) (Drug); Generic formulation of Levothyroxine (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
2.455; 2.131; 0.788; 3.053; 3.112; 1.217 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00403390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.