drugset / Trial / NCT03514732

Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders

NCT03514732

Phase 1 Completed 40 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: * To estimate the range of improvement of NOVANUIT® triple action on following parameters: time for getting asleep, sleep time, number of nocturnal awakening, number of nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score from 0 to 10). * To estimate persistency of NOVANUIT® triple action effects after end of study product consumption. * To assess dependency to NOVANUIT® triple action after study product cessation. * To assess tolerance of NOVANUIT® triple action during the study.

Timeline

Start
2017-03-17
Primary completion
2017-07-05
Completion
2017-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 2 unknown Oral

Indications