UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002559 |
|---|---|
| Receipt number | R000002795 |
| Scientific Title | A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2011/03/30 15:22:20 |
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Basic information
Public title
A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers
Acronym
A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers
Scientific Title
A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers
Scientific Title:Acronym
A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology | Hematology and clinical oncology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Large clinical trials have indicated that early aspirin treatment reduces mortality from acute myocardial infarction. However, it has not been clarified whether chewing low-dose aspirin tablets (compressed non-enteric aspirin and enteric coated aspirin) indeed increase plasma aspirin level, block thromboxane A2 synthesis and inhibit platelet aggregation in a short period of time. This study is aimed to compare immediate action of both chewed and just swallowed Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-course of platelet aggregation inhibition
Key secondary outcomes
Time-course of plasma concentration of aspirin after oral administration, pharmacokinetic parameters (Tmax, AUC), Time-course of plasma TXB2 level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Bufferin 81mg tablets, just swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, chewed and then swallowed
> washout for 2 weeks >
Bayaspirin 100mg, just swallowed
> washout for 2 weeks >
Bayaspirin 100mg, chewed and then swallowed
Interventions/Control_2
Bufferin 81mg tablets, chewed and then swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, just swallowed
> washout for 2 weeks >
Bayaspirin 100mg, chewed and then swallowed
> washout for 2 weeks >
Bayaspirin 100mg, just swallowed
Interventions/Control_3
Bayaspirin 100mg, just swallowed
> washout for 2 weeks >
Bayaspirin 100mg, chewed and then swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, just swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, chewed and then swallowed
Interventions/Control_4
Bayaspirin 100mg, chewed and then swallowed
> washout for 2 weeks >
Bayaspirin 100mg, just swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, chewed and then swallowed
> washout for 2 weeks >
Bufferin 81mg tablets, just swallowed
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers who
1) aged 20 to 50 years, both sexes
2) exhibited normal platelet aggregation in pre-examination
3) gave their written informed consent
Key exclusion criteria
1) history of hypersensitivity to ingredients of Bufferin 81mg tablets, Bayaspirin 100mg or salicylic acid formulation
2) history of aspirin asthma
3) use of non-steroidal anti-inflammatory drugs (NSAIDs) within past 2 weeks
4) antiplatelet agent dosed within past 2 weeks
5) anticoagulation drug dosed within past 2 weeks
6) odontectomy or other invasive operation scheduled within past 2 weeks
7) peptic ulcer disease
8) pregnancy, parturition or lactation
9) bleeding tendency
10) hypermenorrhea
11) drink alcohol on a regular basis
12) reflux esophagitis
13) other situation that doctor decides
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Miyamoto |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
13-1 Takara-machi, Kanazawa 920-8641
TEL
076-265-2045
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Sai |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
TEL
076-265-2046
Homepage URL
sai-ys@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 29 | Day |
Last modified on
| 2011 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002795
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