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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: June 2003

Interventions

  • Drug: Songha® Night
  • Drug: Oxazepam
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Songha® Night
  • Active Comparator: Placebo + Oxazepam
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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