Safety and Efficacy of a Combination Product for the Prevention of Veisalgia

NCT02737397 | Completed Phase 2 Results

• 1 other identifier: JMI-001-001
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Veisalgia

Outcome Measures

Primary Outcomes (1)

• 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).

  24 hours

Study Arms (4)

pain medicine and antihistamine

EXPERIMENTAL

JMI-001 (SJP-304 and SJP-223)

Drug: JMI-001 (SJP-304 and SJP-223)

pain medicine

ACTIVE COMPARATOR

SJP-304 and placebo

Drug: SJP-304; Drug: placebo

antihistamine

ACTIVE COMPARATOR

SJP-223 and placebo

Drug: SJP-223; Drug: placebo

placebo

PLACEBO COMPARATOR

placebo and placebo

Drug: placebo

Interventions

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

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Sen-Jam Pharmaceutical: lead

Limitations and Caveats

Participants were not tested and excluded for hangover insensitivity, prior to being entered into the study.

Results Point of Contact

• Title: Magdy Shenouda, MD
• Organization: Clinilabs, Inc

Jackie@sen-jam.com

201-417-7765

Study Officials

• Magdy L Shenouda

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 19, 2018
• Results First Posted: July 19, 2018

Record last verified: 2018-07