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NCT01598259 · ClinicalTrials.gov registry record · Phase 2

Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

A Phase 2 study, sponsored by Shriners Hospitals for Children.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT01598259 is a Phase 2 study that was terminated before completion, run by Shriners Hospitals for Children. The registered enrollment target is 10 participants.

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The verdict

NCT01598259, a Phase 2 study, was terminated before completion, sponsored by Shriners Hospitals for Children.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.

Interventions

  • DRUG Melatonin
  • OTHER placebo

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2014-05
Est. Completion 2016-06
Phase Phase 2

Sponsor

Shriners Hospitals for Children

40 total trials

What the Registry Record Tells You About NCT01598259

The ClinicalTrials.gov registry entry for NCT01598259 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shriners Hospitals for Children, which has 40 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.

NCT01598259 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01598259 about?

NCT01598259 is a clinical study titled "Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation". The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodol...

What is the current status of trial NCT01598259?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01598259?

The interventions under investigation include: Melatonin (DRUG), placebo (OTHER).

Who is sponsoring clinical trial NCT01598259?

This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.

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

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.