NCT02199847CompletedPhase 2
An Evaluation of the Effects of Pharmaton® Caplets Film-coated Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shifts: a Double-blind, Placebo Controlled Pilot Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 32
- Primary Endpoint
- Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Pharmaton® Caplets
Experimental
Intervention: Pharmaton® Caplets (Drug)
Outcomes
Primary Outcomes
Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
Time Frame: at day 77
Secondary Outcomes
- Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)(up to day 77)
- Assessment of spontaneous Electroencephalogram (EEG) and event related potentials(up to day 77)
- Evaluation of Quality of life scales(up to day 77)
- Assessment of tolerability by subject on a 4-point scale(Day 41, Day 77)
- Assessment of Sleep-Electroencephalogram parameters(Day -1, Day 1, Day 77)
- Evaluation of Sleep by Visual Analogue Scale (VAS)(up to day 77)
- Assessment of 24-hours holter Electrocardiogram (ECG)(Day -1, Day1, Day 77)
- Assessment of urinary cortisol levels(Day -1, Day1, Day 77)
- Number of patients with adverse events(up to 3 months)
- Assessment of tolerability by investigator on a 4-point scale(at day 77)
Investigators
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