NCT03514732

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

An Open Label, Single Arm, Exploratory Study to Estimate the Range of Improvement of the Quality of Sleep With NOVANUIT® Triple Action in Subjects With Mild to Moderate Sleep Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study participation duration for each participant will be 4 weeks including a 2-week treatment period.

Conditions

• Sleep Disorder (Healthy Volunteers)

Interventions

Type	Name	Description
DRUG	MELATONIN (MELATL07959)	Pharmaceutical form:Capsule Route of administration: Oral

Timeline

• Start date: 2017-03-17
• Primary completion: 2017-07-05
• Completion: 2017-07-05
• First posted: 2018-05-02
• Last updated: 2022-04-25

Locations

1 site across 1 country: Poland