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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004475
Receipt No. R000005251
Scientific Title Clinical trial about influence of loxoprofen sodium on the antiplatelet effect of aspirin
Date of disclosure of the study information 2010/11/01
Last modified on 2011/03/08

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Basic information
Public title Clinical trial about influence of loxoprofen sodium on the antiplatelet effect of aspirin
Acronym Interaction between aspirin and loxoprofen sodium
Scientific Title Clinical trial about influence of loxoprofen sodium on the antiplatelet effect of aspirin
Scientific Title:Acronym Interaction between aspirin and loxoprofen sodium
Region
Japan

Condition
Condition Healthy male volunteers
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate influence on antiplatelet effect of aspirin with loxoprofen sodium.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Platelet aggregation activity (platelet aggregation threshold index: PATI)
Serum thromboxane B2 concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 aspirin (one time a day: after breakfast)
Interventions/Control_2 loxoprofen sodium (three times a day: after every meal)
Interventions/Control_3 aspirin (one time a day: after breakfast)
loxoprofen sodium (three times a day: after every meal)
Aspirin and loxoprofen sodium are taken at the same time after breakfast.
Interventions/Control_4 aspirin (one time a day: after breakfast)
loxoprofen sodium (three times a day: after every meal)
Aspirin is taken two hours before loxoprofen sodium after breakfast.
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
45 years-old >=
Gender Male
Key inclusion criteria Healthy male volunteers
Key exclusion criteria In case of corresponding to a warning in package inserts of aspirin and loxoprofen sodium.
Subjects who have never taken either aspirin or NSAIDs.
Subjects who have some hypersensitivities to a medicine.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Aoyama
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki, Noda-shi, Chiba 278-8510, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuuki Akagi
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki, Noda-shi, Chiba 278-8510, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tokyo University of Science
Institute
Department

Funding Source
Organization Tokyo University of Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The PATI in taking both drugs (at the same time) was 2.20+/-0.43 mcg/mL, it was suggested that antiplatelet effect of aspirin has been decreased because of weak platelet COX-1 inhibition.  On the other hand, that in taking both drugs (aspirin before loxoprofen sodium) was 5.29+/-0.59 mcg/mL, similar to aspirin only (5.51+/-0.59 mcg/mL).  Antiplatelet effect of aspirin was seen to be suppressed by loxoprofen sodium, however this interaction might be avoided by taking aspirin two hours before loxoprofen sodium in the morning. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 29 Day
Last modified on
2011 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005251

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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