HealthyPhase 1NCT02273453
Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets
A Phase 1 study testing Songha® Night and Oxazepam in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Songha® Night and Oxazepam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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 to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night
- Conditions
- Healthy
- Being tested
- Songha® Night, Oxazepam, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Songha® NightDrug
OxazepamDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Songha® Night | Experimental | Not described Receives: Drug: Songha® Night |
| Placebo + Oxazepam | Active comparator | Not described Receives: Drug: Oxazepam; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test
Measured: 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
Measured: up to day 36
Change in subjective sleepiness rated on a 7 point scale
Stanford Sleepiness Scale
Measured: up to day 36
Change in subjective sleepiness measured on a visual analogue scale (VAS)
Measured: up to day 36
Change in sleep quality measured on a visual analogue scale (VAS)
Measured: up to day 36
Global Assessment of tolerability by investigator on 4-point scale
Measured: Day 36
Global Assessment of tolerability by patient on 4-point scale
Measured: Day 36
Number of subjects with adverse events
Measured: up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startFeb 2003
- Primary completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273453
- Sponsor's protocol ID
- 582.2
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02273453
- Acronym / sponsor ID
- 582.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Jun 2003 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Songha® Night | Experimental | Drug: Songha® Night |
| Placebo + Oxazepam | Active comparator | Drug: Oxazepam, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Songha® Night | Drug | Songha® Night |
| Oxazepam | Drug | Placebo + Oxazepam |
| Placebo | Drug | Placebo, Placebo + Oxazepam |
Primary outcome
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
7 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Songha® Night and Oxazepam in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.