Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-04 @ 4:57 PM
Study NCT ID:
NCT03514732
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2018-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1195-6610 | OTHER | UTN | View |