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

Phase 1

Completed

• Conditions: Sleep Disorder (Healthy Volunteers)
• Interventions: Drug: MELATONIN (MELATL07959)

• Registration Number: NCT03514732
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2017-03-17
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novanuit® Triple Action	MELATONIN (MELATL07959)	2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.

Primary Outcome Measures

Name	Time	Method
Comparison of the sleep quality	From baseline to Day 21	Difference in the average score of sleep quality

Secondary Outcome Measures

Name	Time	Method
Comparison of mean tiredness	From baseline to Day 28	Difference in the average score of mean tiredness
Comparison of the average scores of sleep quality	From baseline to Day 28	Difference in the average score of sleep quality
Comparison of time for getting asleep	From baseline to Day 28	Difference in the average score of time for getting asleep
Comparison of sleep time	From baseline to Day 28	Difference in the average score of sleep time
Comparison of number of nocturnal awakening	From baseline to Day 28	Difference in the average score of number of nocturnal awakening
Comparison of number of nightmares	From baseline to Day 28	Difference in the average score of number of nightmares
Comparison of awakening quality	From baseline to Day 28	Difference in the average score of awakening quality
Dependency questionnaire	At Day 28	Assessment of product's effects dependency at Day 28
Adverse events (AEs)	From baseline to Day 28	Number of participants with AEs

Trial Locations

Locations (1)

Sanofi Administrative Office; 🇵🇱 Gdańsk, Poland