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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018650
Receipt No. 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

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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
Email 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
Email hiratayuya1981560224@yahoo.co.jp

Sponsor
Institute Department of Dentistry, Seishyukai clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021595

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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