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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031689
Receipt No. R000036184
Scientific Title Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis
Date of disclosure of the study information 2018/03/12
Last modified on 2018/03/12

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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
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
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
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
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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