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

NCT ID: NCT02199847

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30

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

Conditions

Sleep Disorders, Circadian Rhythm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pharmaton® Caplets

Group Type: EXPERIMENTAL

Pharmaton® Caplets

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Pharmaton® Caplets

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1114.11

Identifier Type: -

Identifier Source: org_study_id