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

NCT02273453 | Completed Phase 1

• 1 other identifier: 582.2
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

Songha® Night

EXPERIMENTAL

Drug: Songha® Night

Placebo + Oxazepam

ACTIVE COMPARATOR

Drug: Oxazepam; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Songha® Night DRUG

Songha® Night

Oxazepam DRUG

Placebo + Oxazepam

Placebo DRUG

Placebo; Placebo + Oxazepam

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Oxazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: February 1, 2003
• Primary Completion: June 1, 2003
• Last Updated: October 24, 2014

Record last verified: 2014-10