UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Title of the study (Brief title)	Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology
Region	Japan

Condition
Condition	acute rhinosinusitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study compared the clinical efficacy of garenoxacin and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary efficacy are determined by the patients with SNOT-16 (day 3-4).
Key secondary outcomes	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

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	Garenoxacin 400mg once daily for 7-14day
Interventions/Control_2	Levofloxacin 500mg once daily for 7-14day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	(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
Target sample size	200

Research contact person
Name of lead principal investigator	Tomokazu Yoshizaki
Organization	Graduate School of Medical Science, Kanazawa University
Division name	Dept. Otolaryngology-Head and Neck Surgery
Address	13-1 Takara-machi, Kanazawa 920-8640, JAPAN
TEL	81-76-265-2413
Email	tomoy@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Takayoshi Ueno
Organization	Hokuriku otolaryngology practiced expert study group
Division name	Executive office
Address	13-1 Takara-machi, Kanazawa, Ishikawa 920-8640, Japan
TEL	81-76-265-2413
Homepage URL
Email	uenotaka@med.kanazawa-u.ac.jp

Sponsor
Institute	Hokuriku otolaryngology practiced expert study group
Institute
Department

Funding Source
Organization	Taisho Toyama Pharmaceutical Co., Ltd. Astellas Phama Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

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）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 27 Day
Anticipated trial start date	2013 Year 11 Month 28 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 30 Day
Date analysis concluded	2016 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 27 Day
Last modified on	2018 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014539