UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013503
Receipt number 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 13:45:50

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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 or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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