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NCT04747275 · ClinicalTrials.gov registry record · Phase 4
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
A Phase 4 study, sponsored by Children's Mercy Hospital Kansas City.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT04747275: Clinical Trial Phase 4 study, sponsored by Children's Mercy Hospital Kansas City.
NCT04747275 is a Phase 4 study that was terminated before completion, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747275, a Phase 4 study, was terminated before completion, sponsored by Children's Mercy Hospital Kansas City.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
Utilize medication tolerability questionnaire, Care Children's Acceptance Tool (CAT), to understand parental perceptions of liquid stable L-T4.
Interventions
- DRUG Liquid stable levothyroxine (L-T4) Tirosint-SOL
- DRUG Oral tablet levothyroxine (L-T4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 4 |
Why NCT04747275 stopped before completion
NCT04747275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Liquid stable levothyroxine (L-T4) Tirosint-SOL is the first listed.
NCT04747275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04747275 about?
NCT04747275 is a clinical study titled "Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients". 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 ...
What is the current status of trial NCT04747275?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2021-01-18. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT04747275?
The interventions under investigation include: Liquid stable levothyroxine (L-T4) Tirosint-SOL (DRUG), Oral tablet levothyroxine (L-T4) (DRUG).
Who is sponsoring clinical trial NCT04747275?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04747275's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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