UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial of Loxoprofen for the Treatment of Hangover
Title of the study (Brief title)	Hangovercome Study
Region	Japan

Condition
Condition	Hangover
Classification by specialty	Medicine in general Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of loxoprofen sodium for the alleviation of the symptoms of a hangover
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference in severity of general fatigue before and 3 hours after taking the test drugs using VAS
Key secondary outcomes	1. The difference in the severity of headache before and 3 hours after taking the test drugs using VAS 2. The difference in the severity of nausea before and 3 hours after taking the test drugs using VAS 3. The incidence of an adverse event 4. The changes in the impression of performing a clinical study before and after participating in this randomised controlled trialusing VAS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Loxoprofen 60mg once orally
Interventions/Control_2	Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	Meet all of the following 1. Medical doctor in Japan 2. Participants who can drink alcohol and may experience hangovers with the symptom of general fatigue during the study period 3. Participants who are able to understand the study and gave informed consent on their own
Key exclusion criteria	Current or history of 1. Peptic ulcer 2. Haematological disorder 3. Abnormal liver function 4. Abnormal kidney function 5. Abnormal heart function 6. Malignancy 7. Hypersensitivity to loxoprofen sodium 8. Aspirin-induced asthma 9. Psychiatric disorder 10. Steroid usage 11. Routine usage of NSAIDs 12. Routine usage of other pain killer, including aspirin 13. Routine usage of antiemetic 14. Possibility of pregnancy 15. Participant in a clinical study within 3 months 16. Other inappropriate candidates judged by investigators
Target sample size	500

Research contact person
Name of lead principal investigator	Masahiko Hara
Organization	Japan Society of Clinical Research
Division name	The President
Address	Osaka Ekimae 4th Building 10F Kitaku-Umeda 1-11-4-1000, Osaka, Japan, 530-0001
TEL	06-6131-5495
Email	hara@japanscr.org

Public contact
Name of contact person	Masahiko Hara
Organization	Japan Society of Clinical Research
Division name	Secretariat
Address	Osaka Ekimae 4th Building 10F Kitaku-Umeda 1-11-4-1000, Osaka, Japan, 530-0001
TEL	06-6131-5495
Homepage URL	https://www.japanscr.org/
Email	hara@japanscr.org

Sponsor
Institute	Japan Society of Clinical Research
Institute
Department

Funding Source
Organization	crowd-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日本臨床研究学会（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 05 Month 05 Day
Date of closure to data entry	2018 Year 05 Month 05 Day
Date trial data considered complete	2018 Year 05 Month 05 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 29 Day
Last modified on	2018 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032557