Unique ID issued by UMIN | UMIN000028441 |
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Receipt number | R000032557 |
Scientific Title | Randomized Controlled Trial of Loxoprofen for the Treatment of Hangover |
Date of disclosure of the study information | 2017/07/30 |
Last modified on | 2018/06/09 13:35:00 |
Randomized Controlled Trial of Loxoprofen for the Treatment of Hangover
Hangovercome Study
Randomized Controlled Trial of Loxoprofen for the Treatment of Hangover
Hangovercome Study
Japan |
Hangover
Medicine in general | Emergency medicine |
Others
NO
To evaluate the efficacy of loxoprofen sodium for the alleviation of the symptoms of a hangover
Efficacy
Confirmatory
Pragmatic
Not applicable
The difference in severity of general fatigue before and 3 hours after taking the test drugs using VAS
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Loxoprofen 60mg once orally
Placebo
20 | years-old | <= |
110 | years-old | >= |
Male and Female
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
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
500
1st name | |
Middle name | |
Last name | Masahiko Hara |
Japan Society of Clinical Research
The President
Osaka Ekimae 4th Building 10F Kitaku-Umeda 1-11-4-1000, Osaka, Japan, 530-0001
06-6131-5495
hara@japanscr.org
1st name | |
Middle name | |
Last name | Masahiko Hara |
Japan Society of Clinical Research
Secretariat
Osaka Ekimae 4th Building 10F Kitaku-Umeda 1-11-4-1000, Osaka, Japan, 530-0001
06-6131-5495
https://www.japanscr.org/
hara@japanscr.org
Japan Society of Clinical Research
crowd-funding
Self funding
Japan
NO
日本臨床研究学会(大阪府)
2017 | Year | 07 | Month | 30 | Day |
Unpublished
Completed
2017 | Year | 04 | Month | 26 | Day |
2017 | Year | 08 | Month | 01 | Day |
2018 | Year | 05 | Month | 05 | Day |
2018 | Year | 05 | Month | 05 | Day |
2018 | Year | 05 | Month | 05 | Day |
2017 | Year | 07 | Month | 29 | Day |
2018 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032557
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