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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002559
Receipt No. 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

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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
Email

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
Email sai-ys@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002795

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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