CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
MELATONIN (HIGH DOSE) +2 moredrug
Likely dose
MELATONIN (HIGH DOSE) 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03524937
NCT03524937Phase 3Completed
CompareCT.gov

Prevention of Delirium in Intensive Care by Melatonin: a Prospective, Multicentre, Randomized, Double Blind, Placebo, Multi-arm, Multi-stage Study

Assistance Publique - Hôpitaux de Paris·interventional·Posted May 15, 2018·Updated May 15, 2023

In Brief

A Phase 3 clinical trial evaluating MELATONIN (HIGH DOSE), MELATONIN (LOW DOSE), and 1 other intervention for Mechanically Ventilated Patients. Completed, enrolled 355 participants across 1 site.

Detailed Summary

This is a double-blind, randomized, placebo-controlled, Phase 2b/3 two-part adaptive clinical trial. The trial is designed to investigate the pharmacokinetics and the efficacy of multiple dosing regimens of melatonin and to confirm the efficacy and safety of one dosing regimen in prevention for delirium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMechanically Ventilated Patients
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartFeb 1, 2019
Primary CompletionMay 1, 2021
Study CompletionMay 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.1 years ago

Interventions

MELATONIN (HIGH DOSE)drug

Enteral melatonin (3mg) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

MELATONIN (LOW DOSE)drug

Enteral melatonin (0.3mg ) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

PLACEBOdrug

Study drug will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days.