UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018650 |
|---|---|
| Receipt number | R000021595 |
| Scientific Title | A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia |
| Date of disclosure of the study information | 2015/08/12 |
| Last modified on | 2017/05/08 12:41:59 |
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Basic information
Public title
A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Acronym
A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Scientific Title
A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Scientific Title:Acronym
A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effecacy of flurbiprofen axietil and acetaminophen on preemptive analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
degree of pain after dental implant surgery
Key secondary outcomes
amount of oral analgesic agent after dental implant surgery and period until oral analgesic agent is taken
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous administration of normal saline before surgery
Interventions/Control_2
intravenous administration of flurbiprofen axetil before surgery
Interventions/Control_3
intravenous administration of acetaminophen before surgery
Interventions/Control_4
intravenous administration of flurbiprofen axetil and acetaminophen normal saline before surgery
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients scheduled for dental implant surgery
Key exclusion criteria
Patients with allergy for flurbiprofen axetil and/or acetaminophen
Patient with aspirin-induced asthma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Son Hiroki |
Organization
Seishyukai clinic
Division name
Dentistry
Zip code
Address
Kumata 1-4-20, Higashi sumiyoshi ku, Osaka
TEL
06-6713-9592
mukr57217@iris.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirata Yuya |
Organization
Seishyukai clinic
Division name
Dentistry
Zip code
Address
Kumata 1-4-20, Higashi sumiyoshi ku, Osaka
TEL
06-6713-9592
Homepage URL
hiratayuya1981560224@yahoo.co.jp
Sponsor or person
Institute
Department of Dentistry, Seishyukai clinic
Institute
Department
Personal name
Funding Source
Organization
Department of Dentistry, Seishyukai clinic
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
青洲会診療所(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021595
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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