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

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ClinicalTrials.gov Identifier: NCT03514732
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Disorder (Healthy Volunteers) Drug: MELATONIN (MELATL07959) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : July 5, 2017
Actual Study Completion Date : July 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Novanuit® Triple Action
2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.
Drug: MELATONIN (MELATL07959)
Pharmaceutical form:Capsule Route of administration: Oral




Primary Outcome Measures :
  1. Comparison of the sleep quality [ Time Frame: From baseline to Day 21 ]
    Difference in the average score of sleep quality


Secondary Outcome Measures :
  1. Comparison of the average scores of sleep quality [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of sleep quality

  2. Comparison of time for getting asleep [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of time for getting asleep

  3. Comparison of sleep time [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of sleep time

  4. Comparison of number of nocturnal awakening [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of number of nocturnal awakening

  5. Comparison of number of nightmares [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of number of nightmares

  6. Comparison of awakening quality [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of awakening quality

  7. Comparison of mean tiredness [ Time Frame: From baseline to Day 28 ]
    Difference in the average score of mean tiredness

  8. Adverse events (AEs) [ Time Frame: From baseline to Day 28 ]
    Number of participants with AEs

  9. Dependency questionnaire [ Time Frame: At Day 28 ]
    Assessment of product's effects dependency at Day 28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Healthy men or women volunteers, aged from 20 to 75 years included at the moment of the inclusion visit.
  • 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.

Exclusion criteria:

  • Subject having consumed medications for sleep disorders (sleeping pills) during the 6 months previous the inclusion visit and throughout the study duration.
  • Subject having consumed dietary supplements for sleep disorders during the 3 months previous to inclusion visit and throughout the study duration.
  • 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 consuming products with impact on sleep deterioration at the moment of inclusion visit and throughout the study duration, belong to investigator.
  • Subject having undergone general anesthesia during the month previous to inclusion visit.
  • 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.).
  • Subject taking part in another clinical trial simultaneously and/or in the month previous to inclusion visit and/or being in exclusion period of a previous clinical trial.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514732


Locations
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Poland
Sanofi Administrative Office
Gdańsk, Poland
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03514732     History of Changes
Other Study ID Numbers: MELATL07959
U1111-1195-6610 ( Other Identifier: UTN )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants