Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403390
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2006-11-21
Brief Title:
Generic vs Name-Brand Levothyroxine
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Generic vs Name-Brand Levothyroxine Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None