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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
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts 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

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

    First Posted
    July 24, 2014
    Last Updated
    July 24, 2014
    Sponsor
    Boehringer Ingelheim
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    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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