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

NCT02199847 | Completed Phase 2

• 1 other identifier: 1114.11
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)

  up to day 77

• Assessment of spontaneous Electroencephalogram (EEG) and event related potentials

  up to day 77

• Assessment of Sleep-Electroencephalogram parameters

  Day -1, Day 1, Day 77

• Evaluation of Quality of life scales

  up to day 77

• Evaluation of Sleep by Visual Analogue Scale (VAS)

  up to day 77

Study Arms (2)

Pharmaton® Caplets

EXPERIMENTAL

Drug: Pharmaton® Caplets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pharmaton® Caplets DRUG

Pharmaton® Caplets

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: June 1, 2000
• Primary Completion: January 1, 2001
• Last Updated: July 25, 2014

Record last verified: 2014-07