Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
Primary Purpose
Sleep Disorders, Circadian Rhythm
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pharmaton® Caplets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pharmaton® Caplets
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
Secondary Outcome Measures
Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)
Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
Assessment of Sleep-Electroencephalogram parameters
Evaluation of Quality of life scales
Evaluation of Sleep by Visual Analogue Scale (VAS)
Assessment of 24-hours holter Electrocardiogram (ECG)
Assessment of urinary cortisol levels
Number of patients with adverse events
Assessment of tolerability by investigator on a 4-point scale
Assessment of tolerability by subject on a 4-point scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199847
Brief Title
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmaton® Caplets
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pharmaton® Caplets
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)
Time Frame
up to day 77
Title
Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
Time Frame
up to day 77
Title
Assessment of Sleep-Electroencephalogram parameters
Time Frame
Day -1, Day 1, Day 77
Title
Evaluation of Quality of life scales
Time Frame
up to day 77
Title
Evaluation of Sleep by Visual Analogue Scale (VAS)
Time Frame
up to day 77
Title
Assessment of 24-hours holter Electrocardiogram (ECG)
Time Frame
Day -1, Day1, Day 77
Title
Assessment of urinary cortisol levels
Time Frame
Day -1, Day1, Day 77
Title
Number of patients with adverse events
Time Frame
up to 3 months
Title
Assessment of tolerability by investigator on a 4-point scale
Time Frame
at day 77
Title
Assessment of tolerability by subject on a 4-point scale
Time Frame
Day 41, Day 77
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
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