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)

Sponsors

Lead Sponsor: Boehringer Ingelheim

Source Boehringer Ingelheim
Brief Summary

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

Overall Status Completed
Start Date February 2003
Primary Completion Date June 2003
Phase Phase 1
Study Type Interventional
Primary 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
Measure 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 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
Enrollment 54
Condition
Intervention

Intervention Type: Drug

Intervention Name: Songha® Night

Arm Group Label: Songha® Night

Intervention Type: Drug

Intervention Name: Oxazepam

Arm Group Label: Placebo + Oxazepam

Intervention Type: Drug

Intervention Name: Placebo

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

October 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Songha® Night

Type: Experimental

Label: Placebo + Oxazepam

Type: Active Comparator

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov