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

NCT03514732 | Completed Phase 1

• 2 other identifiers: MELATL07959U1111-1195-6610
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder (Healthy Volunteers)

Outcome Measures

Primary Outcomes (1)

• Comparison of the sleep quality

  Difference in the average score of sleep quality

  From baseline to Day 21

Secondary Outcomes (9)

• Comparison of the average scores of sleep quality

  From baseline to Day 28

• Comparison of time for getting asleep

  From baseline to Day 28

• Comparison of sleep time

  From baseline to Day 28

• Comparison of number of nocturnal awakening

  From baseline to Day 28

• Comparison of number of nightmares

  From baseline to Day 28

Study Arms (1)

Novanuit® Triple Action

EXPERIMENTAL

2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.

Drug: MELATONIN (MELATL07959)

Interventions

MELATONIN (MELATL07959) DRUG

Pharmaceutical form:Capsule Route of administration: Oral

Novanuit® Triple Action

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (limits included).
• Good general health (based on subject interview about his/her medical history and on clinical exam realized by investigator).
• Subject willing to follow diet recommendations in accordance with hygiene and dietary advice defined in the protocol.
• Subject suffering from mild to moderate sleep disorders assessed by Insomnia Severity Index (ISI) questionnaire completed during the selection and presenting a score between 7 and 22 (limits excluded).
• Subject covered by a social security or insurance.

You may not qualify if:

• Subject presenting history of severe chronic disease (cancer, HIV, renal or hepatic failure, hepatic disorders, inflammatory digestive and known malabsorption diseases, arthritis or chronic respiratory insufficiency, etc.) found to be inconsistent for the study follow up by investigator.
• Subject suffering from a chronic or acute pathology causing sleep disorders.
• Subject suffering from eating disorders (anorexia, bulimia, etc.).
• Subject consuming more than 1.5 packet of tobacco per day (30 cigarettes/day or 27 mg of nicotine/day in electronic cigarette).
• Subject with history of known dependency to drugs or alcohol (consuming more than 3 alcohol units per day). In this study, 1 unit of alcohol is defined as 250 mL of beer, 100 mL of wine or 30 mL of spirits.
• Subject having under the care a child who as constant sleep troubles through the night.
• Subject with irregular working hours (day/night shifts, day/night duties, work trip during the study, etc.).
• Woman planning to be pregnant soon, actually pregnant or lactating.
• Woman without efficient contraceptive method such as: hormonal contraception (including patch, contraceptive ring, etc.), uterine device or any other mechanic contraceptive method, or condom or diaphragm or spermicide, throughout the duration of the study.
• Subject with sensitivity or known allergy to the product used in the study.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi Administrative Office

Gdansk, Poland

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: March 17, 2017
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)