UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031689 |
|---|---|
| Receipt number | 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 19:04:37 |
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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
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
htkym@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university medical center
Otolaryngolgy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036184
