UMIN-CTR Clinical Trial

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
Institute	Nippon Medical School Department of Orthopaedic Surgery
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013244