CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Ramelteon +2 moredrug
Likely dose
Riboflavin 100 mgfrom 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/NCT02324153
NCT02324153Phase 2Completed
CompareCT.gov

A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery

Johns Hopkins University·interventional·Posted Dec 24, 2014·Updated Jun 30, 2020

In Brief

A Phase 2 clinical trial evaluating Ramelteon, Microcrystalline Cellulose, and 1 other intervention for Delirium and 3 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 24, 2014
Enrollment StartMar 24, 2017
Primary CompletionJun 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.5 years ago

Interventions

Ramelteondrug

1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered

Microcrystalline Cellulosedrug

Placebo Comparator

Riboflavin 100 mgdrug

Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)