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NCT03514732
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Phase 1 trial testing MELATONIN (MELATL07959) in Sleep Disorder (Healthy Volunteers) in 40 participants. Completed in 5 July 2017.
5 July 2017
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 17 March 2017 |
| Primary completion | 5 July 2017 |
| Estimated completion | 5 July 2017 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- MELATONIN (MELATL07959) — full drug profile →
Conditions studied
- Sleep Disorder (Healthy Volunteers) — all drugs for Sleep Disorder (Healthy Volunteers) →
Sponsor
Sanofi — full company profile →
Who can join
Adults 20 to 75, any sex, with Sleep Disorder (Healthy Volunteers). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03514732
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03514732 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 25 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03514732.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing