Trial Outcomes & Findings for Safety and Efficacy of a Combination Product for the Prevention of Veisalgia (NCT NCT02737397)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

24 hours

Results posted on

2018-07-19

Participant Flow

This was a 4 way cross-over study where 13 individuals received a single dose of an agent in a randomized sequence. All participants were intended to receive all four interventions.

Participant milestones

Participant milestones
Measure	All Study Participants JMI-001 (SJP-304 and SJP-223), single dose SJP-304 + placebo SJP-223 + placebo placebo + placebo
Overall Study STARTED	13
Overall Study JMI-001	13
Overall Study SJP-304	12
Overall Study SJP-223	13
Overall Study Placebo	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=13 Participants Participants were randomized to receive 4 sequences of drug therapy including placebo.
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Sex: Female, Male Female	5 Participants n=13 Participants
Sex: Female, Male Male	8 Participants n=13 Participants
Veisalgia with pre-determined consumption	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Pain Medicine and Antihistamine n=13 Participants JMI-001 (SJP-304 and SJP-223) JMI-001 (SJP-304 and SJP-223)	Pain Medicine n=12 Participants SJP-304 and placebo SJP-304 placebo	Antihistamine n=13 Participants SJP-223 and placebo SJP-223 placebo	Placebo n=13 Participants Placebo + placebo, single dose
Efficacy of Side Effect Prevention Using the Acute Hangover Scale	6.7 score on a scale Standard Deviation 5.66	4.7 score on a scale Standard Deviation 5.05	7.8 score on a scale Standard Deviation 8.66	6.8 score on a scale Standard Deviation 7.21

POST_HOC outcome

Timeframe: 24 hours

Population: A subset of participants were analyzed post-hoc that were hangover sensitive when compared to placebo.

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).

Outcome measures

Outcome measures
Measure	Pain Medicine and Antihistamine n=5 Participants JMI-001 (SJP-304 and SJP-223) JMI-001 (SJP-304 and SJP-223)	Pain Medicine n=4 Participants SJP-304 and placebo SJP-304 placebo	Antihistamine n=5 Participants SJP-223 and placebo SJP-223 placebo	Placebo n=5 Participants Placebo + placebo, single dose
Efficacy of Side Effect Prevention Using the Acute Hangover Scale (Hangover Sensitive Subpopulation)	7 score on a scale Standard Deviation 4.1	6 score on a scale Standard Deviation 6.5	9 score on a scale Standard Deviation 6.9	13.4 score on a scale Standard Deviation 7.7

Adverse Events

Pain Medicine and Antihistamine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pain Medicine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Antihistamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pain Medicine and Antihistamine n=13 participants at risk JMI-001 (SJP-304 and SJP-223) JMI-001 (SJP-304 and SJP-223)	Pain Medicine n=12 participants at risk SJP-304 and placebo SJP-304 placebo	Antihistamine n=13 participants at risk SJP-223 and placebo SJP-223 placebo	Placebo n=13 participants at risk placebo and placebo placebo
General disorders epigastric pain	7.7% 1/13 • Number of events 1 • 24 hours	0.00% 0/12 • 24 hours	0.00% 0/13 • 24 hours	0.00% 0/13 • 24 hours

Additional Information

Magdy Shenouda, MD

Clinilabs, Inc

Phone: 201-417-7765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place