Adjustment and improvement of metabolic control in night shift workers after administration of melatoni

Phase 1

• Conditions: Insomnia because of disturbed sleep-work-rhythm; MedDRA version: 17.0Level: LLTClassification code 10032168Term: Other insomniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.0Level: PTClassification code 10022443Term: Insomnia related to another mental conditionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005254-30-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-18
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1.Ability to understand and personally sign and date the in-formed consent to participate in the study before completing any study related procedures.
2.White male and female above the age of 18 years inclusive at the time of consent.
3.Night shift workers on regular night shifts with at least 4 night shifts per month during the study period. Subjects must have been on regular night shifts for at least 6 months before inclusion into the study.
4.The subject is co-operative and available for the entire study.
5. Signed and written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Pregnancy or breast feeding.
2.Current or relevant history of physical or psychiatric illness that makes the subject unlikely to fully complete the study, or any condition that presents undue risk from the study procedures.
3.Known autoimmune disease.
4.Evidence of relevant renal insufficiency as indicated by an estimated glomerular filtration rate below 60 ml/min.
5.Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, alkaline phosphatase, or serum bilirubin.
6.Known or suspected intolerance or hypersensitivity to the study medication, closely related compounds, or any of the stated ingredients.
7.Current or history of hereditary galactose-intolerance, lapp-lactose-deficiency or glucose-galactose-malabsorption.
8.Use of melatonin, fluvoxamine, cimetidine, quinolones, car-bamazepine, rifampicine, 5-methoxypsoralene or 8-methoxypsoralene within 4 weeks prior to the inclusion into the study.
9.Long distance travel over more than 3 time zones within 4 weeks prior to study inclusion.
10.Subjects who consume more than 750 mg per day caffeine.
11.Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to inclusion into the study.
12.Inability or difficulties to swallow all investigational medicinal products.
13.Participation in a clinical investigation within the past 4 weeks before first administration of IMP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified