Sleep Disorders, Circadian RhythmPhase 2NCT02199847
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
A Phase 2 study testing Pharmaton® Caplets in people with Sleep Disorders, Circadian Rhythm, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm
- What is being tested?
- Pharmaton® Caplets
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Jan 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
About this study
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
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
- Being tested
- Pharmaton® Caplets, Placebo
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaton® CapletsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pharmaton® Caplets | Experimental | Not described Receives: Drug: Pharmaton® Caplets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
Measured: 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)
Measured: up to day 77
Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
Measured: up to day 77
Assessment of Sleep-Electroencephalogram parameters
Measured: Day -1, Day 1, Day 77
Evaluation of Quality of life scales
Measured: up to day 77
Evaluation of Sleep by Visual Analogue Scale (VAS)
Measured: up to day 77
Assessment of 24-hours holter Electrocardiogram (ECG)
Measured: Day -1, Day1, Day 77
Assessment of urinary cortisol levels
Measured: Day -1, Day1, Day 77
Number of patients with adverse events
Measured: up to 3 months
Assessment of tolerability by investigator on a 4-point scale
Measured: at day 77
Assessment of tolerability by subject on a 4-point scale
Measured: Day 41, Day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2000
- Primary completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199847
- Sponsor's protocol ID
- 1114.11
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02199847
- Acronym / sponsor ID
- 1114.11
- Conditions
- Sleep Disorders, Circadian Rhythm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Jan 2001 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaton® Caplets | Experimental | Drug: Pharmaton® Caplets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaton® Caplets | Drug | Pharmaton® Caplets |
| Placebo | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
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
Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
Time frame: up to day 77
Assessment of Sleep-Electroencephalogram parameters
Time frame: Day -1, Day 1, Day 77
Evaluation of Quality of life scales
Time frame: up to day 77
Evaluation of Sleep by Visual Analogue Scale (VAS)
Time frame: up to day 77
Assessment of 24-hours holter Electrocardiogram (ECG)
Time frame: Day -1, Day1, Day 77
Assessment of urinary cortisol levels
Time frame: Day -1, Day1, Day 77
Number of patients with adverse events
Time frame: up to 3 months
Assessment of tolerability by investigator on a 4-point scale
Time frame: at day 77
Assessment of tolerability by subject on a 4-point scale
Time frame: Day 41, Day 77
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
Related trials for Sleep Disorders, Circadian Rhythm
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pharmaton® Caplets in people with Sleep Disorders, Circadian Rhythm, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.