UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014841
Receipt number R000017247
Scientific Title Comparison of the effectiveness of celecoxib and loxoprofen sodium for postoperative pain in orthopedic patients
Date of disclosure of the study information 2014/08/18
Last modified on 2015/07/11 00:11:57

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Basic information

Public title

Comparison of the effectiveness of celecoxib and loxoprofen sodium for postoperative pain in orthopedic patients

Acronym

Comparison of the analgesic effect for orthopaedic postoperative pain

Scientific Title

Comparison of the effectiveness of celecoxib and loxoprofen sodium for postoperative pain in orthopedic patients

Scientific Title:Acronym

Comparison of the analgesic effect for orthopaedic postoperative pain

Region

Japan


Condition

Condition

patients who were undergone orthopaedic surgery

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the efficacy and safety of celecoxib and loxoprofen in postoperative pain after orthopaedic surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Numeric rating scale

Key secondary outcomes

Occurrence of side effect


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Take cerecoxib (100mg) 2 tablets a day

Interventions/Control_2

Take loxoprofen sodium (60mg) 3 tablets a day

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

Patients who can take celecoxib or loxoprofen sodium for postoperative pain after orthopedic surgery

Key exclusion criteria

1) individuals with diseases of the digestive tract
2) individuals with a history of hypersensitivity or allergy to any component of the test drug preparation
3) individuals with a history of myocardial infarction or angina
4) other individuals judged by the attending physician to be inappropriate for this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Gen Inoue

Organization

Kitasato University

Division name

Orthopaedic Surgery

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8707

Email

ginoue@kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Gen Inoue

Organization

Kitasato University

Division name

Orthopaedic Surgery

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8707

Homepage URL


Email

ginoue@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

北里大学病院(神奈川県)、北里大学東病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

There was no significant difference in the maximum and mean NRS scores on each day between loxoprofen and celecoxib, suggesting a comparable analgesic effect for these 2 NSAIDs. Greater improvement in the NRS score between preadministration (baseline) and 30 minutes or 2 hours after administration was obtained for loxoprofen.

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

2012 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 10 Day

Last follow-up date

2014 Year 09 Month 05 Day

Date of closure to data entry

2014 Year 11 Month 10 Day

Date trial data considered complete

2014 Year 12 Month 02 Day

Date analysis concluded

2015 Year 07 Month 11 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 12 Day

Last modified on

2015 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017247


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name