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

Sleep Disorders, Circadian Rhythm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199847
• Other study ID #: 1114.11
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2014
• Last updated: July 24, 2014
• Start date: June 2000

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: January 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• Pharmaton® Caplets

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)		at day 77	No
Secondary	Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)		up to day 77	No
Secondary	Assessment of spontaneous Electroencephalogram (EEG) and event related potentials		up to day 77	No
Secondary	Assessment of Sleep-Electroencephalogram parameters		Day -1, Day 1, Day 77	No
Secondary	Evaluation of Quality of life scales		up to day 77	No
Secondary	Evaluation of Sleep by Visual Analogue Scale (VAS)		up to day 77	No
Secondary	Assessment of 24-hours holter Electrocardiogram (ECG)		Day -1, Day1, Day 77	No
Secondary	Assessment of urinary cortisol levels		Day -1, Day1, Day 77	No
Secondary	Number of patients with adverse events		up to 3 months	No
Secondary	Assessment of tolerability by investigator on a 4-point scale		at day 77	No
Secondary	Assessment of tolerability by subject on a 4-point scale		Day 41, Day 77	No

External Links

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