Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Oxazepam; Drug: Songha® Night

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Songha® Night	Drug: Songha® Night
Active Comparator: Placebo + Oxazepam	Drug: Placebo; Drug: Oxazepam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test	08:00h, 09:30h, 11:00h at Day 7 of each treament period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test		up to day 36
Change in subjective sleepiness rated on a 7 point scale	Stanford Sleepiness Scale	up to day 36
Change in subjective sleepiness measured on a visual analogue scale (VAS)		up to day 36
Change in sleep quality measured on a visual analogue scale (VAS)		up to day 36
Global Assessment of tolerability by investigator on 4-point scale		Day 36
Global Assessment of tolerability by patient on 4-point scale		Day 36
Number of subjects with adverse events		up to 36 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Oxazepam
• Other Study ID Numbers: 582.2