UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011302
Receipt number R000013244
Scientific Title A clinical study on the efficacy of celecoxib in patients with postoperative pain (A multicenter, randomized, open-label,parallel-group controlled study of celecoxib vs. loxoprofen)
Date of disclosure of the study information 2013/08/01
Last modified on 2020/08/03 13:27:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A clinical study on the efficacy of celecoxib in patients with postoperative pain
(A multicenter, randomized, open-label,parallel-group controlled study of celecoxib vs. loxoprofen)

Acronym

A clinical study on the efficacy of celecoxib in patients with postoperative pain

Scientific Title

A clinical study on the efficacy of celecoxib in patients with postoperative pain
(A multicenter, randomized, open-label,parallel-group controlled study of celecoxib vs. loxoprofen)

Scientific Title:Acronym

A clinical study on the efficacy of celecoxib in patients with postoperative pain

Region

Japan


Condition

Condition

The subjects will be patients who are anticipated to develop postoperative pain that is determined manageable with oral NSAIDs

Classification by specialty

Orthopedics Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The efficacy evaluation will be carried out based on the change in the visual analog scale (VAS) on the morning of postoperative Day 3 from baseline in patients with postoperative pain, and the noninferiority of celecoxib to loxoprofen will be examined. The safety evaluation will be made based on comparison between the treatment groups

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in the VAS on the morning of postoperative Day 3 from baseline
Evaluation method

Key secondary outcomes

(1)Time to analgesic effect after the first administration
(2)Time to disappearance of analgesic effect after the first administration
(3)Changes in the VAS from baseline (1, 2 and 3 hours after study drug administration and Day 2 before breakfast)
(4)Change in the VAS from baseline after study treatment completion (Days 4 and 5 before breakfast)


Base

Study type

Interventional


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

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

celecoxib (400 mg only for the first administration on the start day of treatment, and thereafter at a 200 mg, twice daily for 3 days)

Interventions/Control_2

loxoprofen (at a 60 mg, three times daily for 3 days)

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Men and women aged 20 to 64 years at the time of providing informed consent
2) Inpatient and outpatient
3) Patients whose postoperative pain is determined by the investigator to be manageable with oral NSAIDs
4) Patients who is capable of providing written voluntary consent for study participation and adhering to the protocol.

Key exclusion criteria

1)Patients requiring long-acting anesthesia, epidural anesthesia or patient control analgesia (PCA)
2) Patients who are on antithrombotic treatment
3) Patients with a past or current history of aspirin-induced asthma
4) Patients with a past or current history of hypersensitivity to NSAIDs or sulfonamide (sulfa drugs)
5)Patients with concurrent gastrointestinal bleeding or peptic ulcer
6) Patients with a past or current history of ischemic heart disease (angina pectoris or myocardial infarction), serious arrhythmia, congestive heart failure and cerebrovascular disorder (cerebral infarction, transient ischemic attack, cerebral hemorrhage or subarachnoid hemorrhage). Patients with a history of revascularization (coronary artery, carotid artery, cerebral artery, renal artery, aorta or peripheral artery)
7) Patients with serious complications
8) Women who are pregnant, lactating or possibly pregnant or wishing to become pregnant during the study period.
9) Patients with serious liver or renal disorder, cardiac disease or abnormal blood disease
10) Patients who are determined by the investigator/subinvestigator to be not suitable for the study due to other reasons

Target sample size

230


Research contact person

Name of lead principal investigator

1st name Shinro
Middle name
Last name Takai

Organization

Nippon Medical School

Division name

Orthopaedic surgery

Zip code

113-8603

Address

1-1-5,Sendagi, Bunkyo-ku, Tokyo Japan 113-8603

TEL

03-3822-2131

Email

takai-snr@nms.ac.jp


Public contact

Name of contact person

1st name Norishige
Middle name
Last name Iizawa

Organization

Nippon Medical School

Division name

Orthopaedic surgery

Zip code

113-8603

Address

1-1-5,Sendagi, Bunkyo-ku, Tokyo Japan 113-8603

TEL

03-3822-2131

Homepage URL


Email

n.iizawa@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School
Department of Orthopaedic Surgery

Institute

Department

Personal name



Funding Source

Organization

None

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

Clinical trial Nippon Medical School Main Hospital

Address

1-1-5,Sendagi, Bunkyo-ku, Tokyo Japan 113-8603

Tel

03-3822-2131

Email

clinicaltrial@nms.ac.jp


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

日本医科大学付属病院(東京都)、日本医科大学付属多摩永山病院(東京都)、日本医科大学付属武蔵小杉病院(神奈川県)、日本医科大学付属千葉北総病院(千葉県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 01 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

Suspended

Date of protocol fixation

2012 Year 03 Month 07 Day

Date of IRB

2013 Year 02 Month 17 Day

Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2014 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 29 Day

Last modified on

2020 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013244


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name