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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013503
Receipt No. R000015730
Scientific Title Analgesic efficacy of celecoxib 400mg in patients after oral surgery
Date of disclosure of the study information 2014/03/25
Last modified on 2015/03/25

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Basic information
Public title Analgesic efficacy of celecoxib 400mg in patients after oral surgery
Acronym Analgesic efficacy of celecoxib 400mg in patients after oral surgery
Scientific Title Analgesic efficacy of celecoxib 400mg in patients after oral surgery
Scientific Title:Acronym Analgesic efficacy of celecoxib 400mg in patients after oral surgery
Region
Japan

Condition
Condition Dental pain after mandibular 3rd molar extraction surgery
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of celecoxib for the treatment of postoperative oral surgical pain after extraction of mandibular third molar
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes magnitude of pain relief
Key secondary outcomes patient impression of pain relief
onset of pain relief
changes in pain (VAS score)
use of rescue medication

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 celecoxib
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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

Not applicable
Gender Male and Female
Key inclusion criteria The eligible subjects are patients who will undergo surgical extraction of mandiblar 3rd molar, and need analgesic medication for the treatment of postsurgical pain
Key exclusion criteria Patients as below are excluded
1. with concomitant use of other analgesics before or on the day of surgery
2. undergo surgery with general anesthesia
3. with severe cardiac disease, nephropathy, liver disease, hematologic disease, or hypertension
4. with hypersensitivity to celecoxib
5. with gastrointestinal hemorrhages, or ulcers
6. with aspirin-induced asthma, or the past history
7. if they were pregnant, breastfeeding, with potential pregnancy, or willing to be pregnant during the study
8. inappropriate to participate in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Ota
Organization Tokai University School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 143 Shimo-Kasuya, Isehara, Kanagawa, Japan 259-1193
TEL 0463-93-1121
Email yotaorsg@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Ota
Organization Tokai University School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 143 Shimo-Kasuya, Isehara, Kanagawa, Japan 259-1193
TEL 0463-93-1121
Homepage URL
Email yotaorsg@yahoo.co.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 03 Month 25 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
2013 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 29 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 12 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 25 Day
Last modified on
2015 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015730

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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