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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 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.

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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.

Interventions

  • DRUG Liquid stable levothyroxine (L-T4) Tirosint-SOL
  • DRUG Oral tablet levothyroxine (L-T4)

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-01-18
Est. Completion 2021-11-01
Phase Phase 4

What the Registry Record Tells You About NCT04747275

The ClinicalTrials.gov registry entry for NCT04747275 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Liquid stable levothyroxine (L-T4) Tirosint-SOL is the first listed.

NCT04747275 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.