Status:
COMPLETED
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Sleep Disorders, Circadian Rhythm
Eligibility:
All Genders
20-45 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02199847
Start Date
June 1 2000
Last Update
July 25 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.