NCT02737397

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sen-Jam Pharmaceutical · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	JMI-001 (SJP-304 and SJP-223)
DRUG	SJP-304
DRUG	SJP-223
DRUG	placebo

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-04-13
• Last updated: 2018-07-19
• Results posted: 2018-07-19