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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024363
Receipt No. R000028046
Scientific Title A Comparison of Analgesic Effect between Loxoprofen and Celecoxib and the Frequency of the Hemorrhage Following Tonsillectomy
Date of disclosure of the study information 2016/12/01
Last modified on 2017/04/17

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Basic information
Public title A Comparison of Analgesic Effect between Loxoprofen and Celecoxib
and the Frequency of the Hemorrhage Following Tonsillectomy
Acronym A Comparison of Analgesic Effect between Loxoprofen and Celecoxib
and the Frequency of the Hemorrhage Following Tonsillectomy
Scientific Title A Comparison of Analgesic Effect between Loxoprofen and Celecoxib
and the Frequency of the Hemorrhage Following Tonsillectomy
Scientific Title:Acronym A Comparison of Analgesic Effect between Loxoprofen and Celecoxib
and the Frequency of the Hemorrhage Following Tonsillectomy
Region
Japan

Condition
Condition chronic tonsillitis,peritonsillar abscess,sleep apnea syndrome
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a pain-killer to give after palatine tonsil enucleation, conventional NSAIDs is often chosen. However, because NSAIDs inhibits both of COX-1 and COX-2 nonselectively, I control the platelet aggregation action that is physiological action of COX-1 at the same time, and the possibility that it becomes the factor of the bleeding after art has it pointed out. In contrast, it is said that there are few side effects such as the bleeding tendency because NSAIDs having selective COX-2 inhibition does not control platelet aggregation action. Therefore I examine painkilling effects enough again whether you reduce frequency of the bleeding after art more when it chooses conventional NSAIDs (loxoprofen) to choose selective COX-2 inhibitor (celecoxib) as a pain-killer this time whether you are provided safely.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes On a patient background, the total dosage days of the pain-killer, the self-evaluation (I include VAS scale) for the painkilling effect, a ratio (rescue dosage rate), the days of the case receiving the rescue, a last dosage day, I did it with a side effect after presence of the bleeding and degree, art after a side effect, a hospitalized total eating rate, art at time of the bleeding.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Only as for the first time, I gave 200 mg of once after dinner after the second at 400 mg with celecoxib twice a day for the celecoxib group in morning after the next day five hours after an operation.
Interventions/Control_2 I gave 60 mg of loxoprofen after every meal with 60 mg of once after the second three times a day for the loxoprofen group five hours after an operation only in the first time.
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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients such as tonsillitis chronic in 15 years old or more that enforced both sides palatine tonsil enucleation on January 1, 2017 by December 31, 2017, almond peritonsillar abscess, sleep apnea syndrome.
Key exclusion criteria The Patient of allergy to celecoxib and bronchial asthma is excluded
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Sugiura
Organization Tosei General Hospital
Division name Otolaryngology
Zip code
Address 160, Nishioiwakecho, Seto-shi, Aichi
TEL 0561825101
Email masahirof@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Fukushima
Organization Tosei General Hospital
Division name Otolaryngology
Zip code
Address 160, Nishioiwakecho, Seto-shi, Aichi
TEL 0561825101
Homepage URL
Email masahirof@tosei.or.jp

Sponsor
Institute Tosei General Hospital
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
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
2016 Year 12 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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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