VeisalgiaPhase 2NCT02737397
Safety and Efficacy of a Combination Product for the Prevention of Veisalgia
A Phase 2 study testing JMI-001 (SJP-304 and SJP-223), SJP-304 and SJP-223 in people with Veisalgia, run by Sen-Jam Pharmaceutical.
Trial summary
The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Veisalgia
- What is being tested?
- JMI-001 (SJP-304 and SJP-223), SJP-304 and SJP-223
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, nonsmoking men or women between 25 and 65 years inclusive
- Good general health as determined by a thorough medical history and physical examination including vital signs
- Subject is a self-reported moderate drinker of alcohol. Moderate drinking can be approximated with a blood alcohol concentration (BAC) of 0.04 - 0.11%. The 0.04% - 0.11% BAC correlates approximately with a 120-160 pound female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 160-200 pound male drinking 3 to 7 drinks in 2 to 3 hours, respectively.
- Subject has had a moderate to heavy drinking episode in the past 90 days that produced hangover symptoms
- Subject is knowledgeable of the amount of alcohol he/she needs to consume over a 2 to 3 hour period of time to produce hangover symptoms
- Body mass index between 19 and 32 kg/m2, inclusive
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- Report a regular, habitual bedtime between 21:30 and 24:00
- Females of childbearing potential must be using an acceptable method of contraception (see Section 8.5) or have been surgically sterilized and have a negative urine pregnancy test at screening and upon admission for each treatment visit
- Subject is capable of understanding the requirements of the study and to give written informed consent
- Subject is able to follow study instructions and is willing to complete all study visits and procedures
Who cannot join
- Acute illness within 14 days prior to screening visit
- Allergic reaction or upper respiratory tract infection within 7 days of screening visit
- Vaccination administration within 7 days of screening visit
- Clinically significant, unstable medical illness
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease
- History of cancer or diabetes
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- Subject has a previous or current Substance-Related Disorder as defined by DSM-5
- Self-report of a usual consumption of more than 14 units of alcohol per week. One unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine, or
- 1 ounce of liquor
- Self-report of recent (within one month) or current use of smoked or chewed tobacco products, or use of nicotine (e.g., nicotine gum or patch)
- Positive alcohol breathalyzer test at screening or at check-in for any treatment visit
- Positive urine drug screen at screening or at check-in for any treatment visit
- A supine blood pressure > 140/90 mm/Hg at screening
- Heart rate > 100 beats per minute at screening
- Subjects who are unwilling to forgo caffeine consumption with or following dinner on each treatment night or who are unwilling to comply with study restrictions for prohibited medications/ foods throughout study participation.
- Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition
- Any clinically significant abnormal finding on physical examination or vital signs
- Positive pregnancy test at screening or at check-in for any treatment visit
- Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage, including a reaction of not effective
- Subject is taking any prescription or over-the-counter oral pain medication(s) for any reason
- Subject is taking prescription or over-the-counter antihistamine(s)
- Women who are pregnant or breastfeeding
- Any medical condition or any condition or situation that in the investigator's opinion may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
- Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening
About this study
Official title: A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Volunteers
The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.
Read the detailed description
Some people who consume alcohol in moderation experience veisalgia. These symptoms include a long list of adverse effects that include headache, fatigue and thirst. The mechanism by which these effects occur has not been fully elucidated. Although, it has been documented that alcohol causes the release of a large number of substances into the blood stream that cause a number of physiologic changes.
A 4-arm study will help to determine the effect each agent contributes to decreasing the alcohol induces physiologic changes and the effect when the two agents are delivered concurrently.
- Conditions
- Veisalgia
- Being tested
- JMI-001 (SJP-304 and SJP-223), SJP-304, SJP-223, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMI-001 (SJP-304 and SJP-223)Drug
SJP-304Drug
SJP-223Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| pain medicine and antihistamine | Experimental | JMI-001 (SJP-304 and SJP-223) Receives: Drug: JMI-001 (SJP-304 and SJP-223) |
| pain medicine | Active comparator | SJP-304 and placebo Receives: Drug: SJP-304; Drug: placebo |
| antihistamine | Active comparator | SJP-223 and placebo Receives: Drug: SJP-223; Drug: placebo |
| placebo | Placebo comparator | placebo and placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Side Effect Prevention Using the Acute Hangover Scale
Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VeisalgiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sen-Jam Pharmaceutical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdy L Shenouda, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737397
- Sponsor's protocol ID
- JMI-001-001
- Status last verified
- Jul 2018
- First submitted
- 22 Mar 2016
- Last updated
- 19 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02737397
- Acronym / sponsor ID
- JMI-001-001
- Conditions
- Veisalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sen-Jam PharmaceuticalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 19 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.
Detailed description
Some people who consume alcohol in moderation experience veisalgia. These symptoms include a long list of adverse effects that include headache, fatigue and thirst. The mechanism by which these effects occur has not been fully elucidated. Although, it has been documented that alcohol causes the release of a large number of substances into the blood stream that cause a number of physiologic changes.
A 4-arm study will help to determine the effect each agent contributes to decreasing the alcohol induces physiologic changes and the effect when the two agents are delivered concurrently.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pain medicine and antihistamine | Experimental | Drug: JMI-001 (SJP-304 and SJP-223)JMI-001 (SJP-304 and SJP-223) |
| pain medicine | Active comparator | Drug: SJP-304, Drug: placeboSJP-304 and placebo |
| antihistamine | Active comparator | Drug: SJP-223, Drug: placeboSJP-223 and placebo |
| placebo | Placebo comparator | Drug: placeboplacebo and placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy, nonsmoking men or women between 25 and 65 years inclusive
- Good general health as determined by a thorough medical history and physical examination including vital signs
- Subject is a self-reported moderate drinker of alcohol. Moderate drinking can be approximated with a blood alcohol concentration (BAC) of 0.04 - 0.11%. The 0.04% - 0.11% BAC correlates approximately with a 120-160 pound female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 160-200 pound male drinking 3 to 7 drinks in 2 to 3 hours, respectively.
- Subject has had a moderate to heavy drinking episode in the past 90 days that produced hangover symptoms
- Subject is knowledgeable of the amount of alcohol he/she needs to consume over a 2 to 3 hour period of time to produce hangover symptoms
Key exclusion criteria (24 listed)
- Acute illness within 14 days prior to screening visit
- Allergic reaction or upper respiratory tract infection within 7 days of screening visit
- Vaccination administration within 7 days of screening visit
- Clinically significant, unstable medical illness
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease
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 |
|---|---|---|
| JMI-001 (SJP-304 and SJP-223) | Drug | pain medicine and antihistamine |
| SJP-304 | Drug | pain medicine |
| SJP-223 | Drug | antihistamine |
| placebo | Drug | antihistamine, pain medicine, placebo |
Primary outcome
Efficacy of Side Effect Prevention Using the Acute Hangover Scale
Time frame: 24 hours
Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Veisalgia
Not yet recruitingPhase 2
Rapid BAC Reduction with Nutraceutical Blend Study
Alcohol Consumption, Alcohol
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.
Magdy L Shenouda principal investigator
Clinilabs, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMI-001 (SJP-304 and SJP-223), SJP-304 and SJP-223 in people with Veisalgia, run by Sen-Jam Pharmaceutical.
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 10 inclusion and 24 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 19 Jul 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Side Effect Prevention Using the Acute Hangover Scale (time frame: 24 hours). 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 19 Jul 2018.