UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis
Acronym	Chronic Sinusitis and TJ-50
Scientific Title	Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis
Scientific Title:Acronym	Chronic Sinusitis and TJ-50
Region	Japan

Condition
Condition	Chronic Sinusitis
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to investigate on efficacy and safety of TJ-50 for the patient who diagnosed with chronic sinusitis and received endoscopic sinus surgery. This study was an open-label randomized trial between the groups who treated with TJ-50 or not after ESS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	A score of the QOL by the patient using SNOT-22 at 3 months after the ESS
Key secondary outcomes	1) Nasal mucosal findings (Baba's score) 2) Colony Forming Unit (CFU) in the nasal cavity 3) Olfactory survey (VAS) 4) Laboratory test values (WBC, leukocyte fraction (neutrophils, eosinophils, basophils, lymphocytes, monocytes))

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group received the standard treatment with TJ-50 for 3 months after surgery.
Interventions/Control_2	The group received the standard treatment without TJ-50 for 3 months after surgery.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The patient is diagnosed with chronic sinusitis 2) The patient is planned treatment by ESS( Endoscopic Sinus Surgery) 3) The patient can be treated with long-term, low-dose macrolide. 4) 20 to 80 years old 5) Written informed consent of this study is obtained from the patient
Key exclusion criteria	1) The patients scheduled to undergo surgical procedures other than ESS as a treatment for chronic sinusitis 2) The patients suspected of typical eosinophilic sinusitis 3) The patients complicated of aspirin asthma 4) The patients complicated with bronchial asthma 5) THe patients complicated of NSAIDs allergy 6) Pregnant women, lactating women, and patients who have the possibility or intention of pregnancy 7) The patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study 8) The patients judged unsuitable by researchers
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiromitsu Hatakeyama
Organization	Yokohama city university medical center
Division name	Otolaryngology
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama
TEL	045-261-5656
Email	htkym@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromitsu Hatakeyama
Organization	Otolaryngolgy
Division name	Yokohama city university medical center
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama
TEL	045-261-5656
Homepage URL
Email	htkym@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university medical center Otolaryngolgy
Institute
Department

Funding Source
Organization	Tsumura & Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2018 Year 03 Month 12 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
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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	2018 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 02 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	2018 Year 03 Month 12 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036184

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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