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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Chronic Sinusitis | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Yokohama city university medical center
Otolaryngolgy |
Institute | |
Department |
Funding Source | |
Organization | Tsumura & Co. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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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 |
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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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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |