Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Sleep Disorders, Circadian Rhythm

Treatments

Drug: Placebo

Drug: Pharmaton® Caplets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02199847

1114.11

Details and patient eligibility

About

The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts

Enrollment

32 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female nurses and nursing auxiliaries working night shift
Age range: 20 to 45 inclusive
BMI range: 18-30
Negative pregnancy test for females
Subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures
Clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator
Negative urine drug screen for drugs at screening
Subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules

Exclusion criteria

Any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic Manual, Version IV (DSM-IV)
Individuals drinking more that 6 cups of coffee or tea/day
Individuals smoking more than 10 cigarettes/day
Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine Device (IUD), sterilization)
Pregnancy and/or lactation
Relevant allergy or known hypersensitivity to the investigational product or its excipients
Individuals taking or having taken recently other vitamins and minerals supplementation
Individuals with a current disorder likely to modify EEG recordings and/or computerized cognitive testing
Individuals having a history of cancer
Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial
Individuals without health insurance