Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747275
Status:
TERMINATED
Last Update Posted:
2023-09-13
First Post:
2021-02-03
Brief Title:
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transitioned to multi site study with sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children with levothyroxine T21 have developmental delay and other functional gastrointestinal GI issues that may negatively affect L-T4 tolerability and absorption For an age group unable to swallow tablets whole by mouth tablets must be crushed and suspended in water breast milk or formula for administration in order to treat children with hypothyroidism For this age group ease of administration may have a significant impact on compliance and ability to remain euthyroid We propose that Tirosint-SOL will be more favorably received due to ease of administration improved tolerability and palatability therefore leading to improved adherence when compared to L-T4 tablets
Detailed Description:
Hypothyroidism is a common medical disorder in children with Trisomy 21 T21 Treatment with oral tablet levothyroxine L-T4 is primarily used to treat this condition However children with T21 have developmental delay and other functional gastrointestinal GI issues that may negatively affect L-T4 tolerability and absorption For an age group unable to swallow tablets whole by mouth tablets must be crushed and suspended in water breast milk or formula for administration in order to treat children with hypothyroidism For this age group ease of administration may have a significant impact on compliance and ability to remain euthyroid Until recently there was no liquid preparation of L-T4 in the United States for use in children Tirosint-SOL liquid stable L-T4 is now FDA-approved for use in children The Investigator proposes that Tirosint-SOL will be more favorably received due to ease of administration improved tolerability and palatability therefore leading to improved adherence when compared to L-T4 tablets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None