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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028441
Receipt No. R000032557
Official scientific title of the study 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

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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