UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016541
Receipt number R000019200
Scientific Title The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)
Date of disclosure of the study information 2015/03/01
Last modified on 2021/04/15 00:58:10

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Basic information

Public title

The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)

Acronym

MELIt Trial

Scientific Title

The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)

Scientific Title:Acronym

MELIt Trial

Region

Japan


Condition

Condition

Patients who are at least 20 years, and are admitted to an emergency and medical ICU in our hospital.

Classification by specialty

Medicine in general Surgery in general Anesthesiology
Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We study to clarify the efficacy of ramelteon, which has effect for anti-imflamention and prevention of the delirium, for ICU patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

The primary outcome is the duration in our emergency and medical ICU admission.

Key secondary outcomes

Key secondary outcomes are 1. the transition of inflammation markers, 2. the incidence, severity of delirium, 3. the mortality rate when they are discharged from our emergency and medical ICU.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We give ramelteon to our emergency and medical ICU patients.

Interventions/Control_2

We give placebo to our emergency and medical ICU patients.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who are at least 20 years, and are admitted to an emergency and medical ICU in our hospital.

Key exclusion criteria

Exclusion criteria is the patient who is contraindicated for ramelteon, who is not receiving ramelteon therapy, who is admitted to our ICU during at least 2 days.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Numaguchi

Organization

Nagoya university hospital.

Division name

The emergency and critical care department.

Zip code


Address

Tsurumai-cho 65, syowa-ku, Nagoya, Aichi, Japan.

TEL

+81-52-744-2659

Email

nummer0116@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuaki Nishikimi

Organization

Nagoya university hospital.

Division name

The emergency and critical care department.

Zip code


Address

Tsurumai-cho 65, syowa-ku, Nagoya, Aichi, Japan.

TEL

+81-52-744-2659

Homepage URL


Email

m0528332626@yahoo.co.jp


Sponsor or person

Institute

The emergency and critical care department, Nagoya university hospital.

Institute

Department

Personal name



Funding Source

Organization

Nagoya university hospital.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/29595562/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/29595562/

Number of participants that the trial has enrolled

88

Results

As the primary endpoint, there was a trend toward decrease in the duration of ICU stay (4.56 d) in the ramelteon group compared with the placebo group (5.86 d) (p = 0.082 and p = 0.028 before and after adjustments).

Results date posted

2021 Year 04 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Eligible patients were ICU patients who could take medicines orally or through a nasogastric tube during the first 48 hours of admission.

Participant flow

A total of 88 subjects were randomized to the ramelteon group (45 subjects) or the placebo group (43 subjects).

Adverse events

None

Outcome measures

the duration of ICU stay

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 09 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 04 Month 30 Day

Date trial data considered complete

2017 Year 05 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 14 Day

Last modified on

2021 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019200


Research Plan
Registered date File name
2017/02/15 研究計画書 .docx

Research case data specifications
Registered date File name

Research case data
Registered date File name