Sleep Disorder (Healthy Volunteers)Phase 1NCT03514732
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
A Phase 1 study testing MELATONIN (MELATL07959) in people with Sleep Disorder (Healthy Volunteers), run by Sanofi at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder (Healthy Volunteers)
- What is being tested?
- MELATONIN (MELATL07959)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 17 Mar 2017to 5 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Study participation duration for each participant will be 4 weeks including a 2-week treatment period.
- Conditions
- Sleep Disorder (Healthy Volunteers)
- Being tested
- MELATONIN (MELATL07959)
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELATONIN (MELATL07959)Drug
Pharmaceutical form:Capsule Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Novanuit® Triple Action | Experimental | 2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime. Receives: Drug: MELATONIN (MELATL07959) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the sleep quality
Difference in the average score of sleep quality
Measured: From baseline to Day 21
Secondary outcomes (9)
Comparison of the average scores of sleep quality
Difference in the average score of sleep quality
Measured: From baseline to Day 28
Comparison of time for getting asleep
Difference in the average score of time for getting asleep
Measured: From baseline to Day 28
Comparison of sleep time
Difference in the average score of sleep time
Measured: From baseline to Day 28
Comparison of number of nocturnal awakening
Difference in the average score of number of nocturnal awakening
Measured: From baseline to Day 28
Comparison of number of nightmares
Difference in the average score of number of nightmares
Measured: From baseline to Day 28
Comparison of awakening quality
Difference in the average score of awakening quality
Measured: From baseline to Day 28
Comparison of mean tiredness
Difference in the average score of mean tiredness
Measured: From baseline to Day 28
Adverse events (AEs)
Number of participants with AEs
Measured: From baseline to Day 28
Dependency questionnaire
Assessment of product's effects dependency at Day 28
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start17 Mar 2017
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514732
- Sponsor's protocol ID
- MELATL07959
- Other IDs
- U1111-1195-6610
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03514732
- Acronym / sponsor ID
- MELATL07959
- Conditions
- Sleep Disorder (Healthy Volunteers)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novanuit® Triple Action | Experimental | Drug: MELATONIN (MELATL07959)2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELATONIN (MELATL07959)Pharmaceutical form:Capsule Route of administration: Oral | Drug | Novanuit® Triple Action |
Primary outcome
Comparison of the sleep quality
Time frame: From baseline to Day 21
Difference in the average score of sleep quality
9 secondary outcomes
Comparison of the average scores of sleep quality
Time frame: From baseline to Day 28
Comparison of time for getting asleep
Time frame: From baseline to Day 28
Comparison of sleep time
Time frame: From baseline to Day 28
Comparison of number of nocturnal awakening
Time frame: From baseline to Day 28
Comparison of number of nightmares
Time frame: From baseline to Day 28
Comparison of awakening quality
Time frame: From baseline to Day 28
Comparison of mean tiredness
Time frame: From baseline to Day 28
Adverse events (AEs)
Time frame: From baseline to Day 28
Dependency questionnaire
Time frame: At Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. 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://vivli.org
Related trials for Sleep Disorder (Healthy Volunteers)
RecruitingPhase 1/2
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
Healthy Volunteers, Alcohol Use Disorder (AUD)
Active, not recruiting
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
Skin Ageing, Healthy Ageing
RecruitingPhase 1
Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
Sleep Deprivation
Recruiting
Effects of Probiotic Supplementation on Stress and Anxiety in Students
Stress, Anxiety
RecruitingObservational study
The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain
Insomnia, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MELATONIN (MELATL07959) in people with Sleep Disorder (Healthy Volunteers), run by Sanofi at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the sleep quality (time frame: From baseline to Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.