UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004475 |
|---|---|
| Receipt number | 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 20:44:17 |
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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
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
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005251
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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