CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 294 enrolled
Drug / intervention
Melatonin 5 mg +1 moredrug
Likely dose
Melatonin 5 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/NCT04795336
NCT04795336Phase 1Completed

Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial

NYU Langone Health·interventional·Posted Mar 12, 2021·Updated May 4, 2025

In Brief

A Phase 1 clinical trial evaluating Melatonin 5 mg and Placebo for Osteo Arthritis Knee. Completed, enrolled 294 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 12, 2021
Enrollment StartJul 12, 2021
Primary CompletionApr 1, 2024
Study CompletionApr 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.3 years ago

Interventions

Melatonin 5 mgdrug

Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg

Placeboother

The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.