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 |
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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
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
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
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
