Unique ID issued by UMIN | UMIN000012421 |
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Receipt number | R000014539 |
Scientific Title | Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology |
Date of disclosure of the study information | 2013/11/28 |
Last modified on | 2018/04/25 13:13:20 |
Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Japan |
acute rhinosinusitis
Oto-rhino-laryngology |
Others
NO
This study compared the clinical efficacy of garenoxacin and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin.
Efficacy
Confirmatory
Pragmatic
Not applicable
The primary efficacy are determined by the patients with SNOT-16 (day 3-4).
1) The efficacy are determined by otorhinolaryngologists with japanese scoring method for acute rhinosinusitis (day 3-4, 6-8, 13-15).
2) The efficacy are determined by the patients with SNOT-16 (day 6-8, 13-15)
3) The efficacy are evaluated by X ray and cultivation of bacteria (day 6-8)
4) The efficacy are evaluated by patients' diary
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Garenoxacin 400mg once daily for 7-14day
Levofloxacin 500mg once daily for 7-14day
20 | years-old | <= |
Not applicable |
Male and Female
Outpatients with a diagnosis of moderate to severe acute rhinosinusitis of presumed bacterial origin have symptoms of acute sinusitis for 5 days or more and radiographic evidence of acute rhinosinusitis.
(1) The patients should be treat with intravenous anitimicobial injection because of severe infectious disease
(2) Purulent specimens are test agent- resistant bacteria.
(3) The patients have improvements in clinical symptoms with another oral antibacterial agent before this examination.
(4) The patients are suspected of recurent or odontogenic sinusitis
200
1st name | |
Middle name | |
Last name | Tomokazu Yoshizaki |
Graduate School of Medical Science, Kanazawa University
Dept. Otolaryngology-Head and Neck Surgery
13-1 Takara-machi, Kanazawa 920-8640, JAPAN
81-76-265-2413
tomoy@med.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Takayoshi Ueno |
Hokuriku otolaryngology practiced expert study group
Executive office
13-1 Takara-machi, Kanazawa, Ishikawa 920-8640, Japan
81-76-265-2413
uenotaka@med.kanazawa-u.ac.jp
Hokuriku otolaryngology practiced expert study group
Taisho Toyama Pharmaceutical Co., Ltd.
Astellas Phama Inc.
Profit organization
NO
金沢大学付属病院(石川県)、金沢医療センター(石川県)、金沢社会保険病院(石川県)、公立松任石川中央病院(石川県)、恵寿総合病院(石川県)、芳珠記念病院(石川県)、富山県立中央病院(富山県)、市立砺波総合病院(富山県)、黒部市民病院(富山県)、公立南砺中央病院(富山県)、高岡市民病院(富山県)、福井県立病院(福井県)、福井県済生会病院(福井県)、自治医科大学付属とちぎ子ども医療センター(栃木県)、市立輪島病院(石川県)、公立宇出津総合病院(石川県)、山中温泉医療センター(石川県)、吉田耳鼻咽喉科医院(石川県)、小森耳鼻咽喉科医院(石川県)、耳鼻咽喉科安田医院(石川県)、山崎耳鼻咽喉科医院(石川県)、串耳鼻咽喉科(石川県)、耳鼻咽喉科しぶたに医院(富山県)、ほりかわクリニック(石川県)、渡辺耳鼻咽喉科医院(石川県)、耳鼻咽喉科堀川医院(福井県)、前川耳鼻咽喉科医院(富山県)、ひろせクリニック(石川県)、河合医院耳鼻咽喉科(富山県)、おんま耳鼻咽喉科クリニック(石川県)
2013 | Year | 11 | Month | 28 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 27 | Day |
2013 | Year | 11 | Month | 28 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 11 | Month | 30 | Day |
2015 | Year | 11 | Month | 30 | Day |
2016 | Year | 05 | Month | 29 | Day |
2013 | Year | 11 | Month | 27 | Day |
2018 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014539
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