Clinical trial NCT02273453: Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled Cross-over Trial to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets (120 mg Valerian / 80 mg Lemon Balm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night


Eligibility criteria: Inclusion Criteria:

* Healthy male or female Caucasian subjects aged 20-60 years
* Normal outcome in Pittsburgh Sleep Quality Index (PSQI), below mean +2 Standard Deviation (SDs)
* No manifest sleep disorder diagnosed by polysomnography
* Normal pupillary function
* Willing and able to give written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to participation in the study and able to perform the study during the full time period of 36 days

Exclusion Criteria:

* Subjective sleep duration of less than 3 hours in the night before the test
* Caffeine, nicotine or alcohol on the day (from midnight) of the test
* Alcohol consumption on the evening before visits 3, 5 or 7
* Eye-drops or other drugs, taken orally or intravenously, influencing pupil size or motility
* Shift work
* Drug and alcohol abuse
* Use of psycho-active drugs during the past 30 days
* Any treatment that might interfere with the evaluation of the test drug
* Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450
* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
* Known hypersensitivity to any of the ingredients of the study drugs
* Pregnant or nursing women or inadequate birth control methods (this applies to female of childbearing potential only)
* Participation in another trial within the past 30 days

Primary outcomes:
measure: Changes from baseline of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test
timeFrame: 08:00h, 09:30h, 11:00h at Day 7 of each treament period
Secondary outcomes:
measure: Change of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test
timeFrame: up to day 36
measure: Change in subjective sleepiness rated on a 7 point scale
timeFrame: up to day 36
measure: Change in subjective sleepiness measured on a visual analogue scale (VAS)
timeFrame: up to day 36
measure: Change in sleep quality measured on a visual analogue scale (VAS)
timeFrame: up to day 36
measure: Global Assessment of tolerability by investigator on 4-point scale
timeFrame: Day 36
measure: Global Assessment of tolerability by patient on 4-point scale
timeFrame: Day 36
measure: Number of subjects with adverse events
timeFrame: up to 36 days
Other outcomes:
Locations:
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