UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012421
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

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Basic information

Public title

Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology

Acronym

Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology

Scientific Title

Garenoxacin versus Levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology

Scientific Title:Acronym

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

1st name
Middle name
Last name Tomokazu Yoshizaki

Organization

Graduate School of Medical Science, Kanazawa University

Division name

Dept. Otolaryngology-Head and Neck Surgery

Zip code


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

1st name
Middle name
Last name Takayoshi Ueno

Organization

Hokuriku otolaryngology practiced expert study group

Division name

Executive office

Zip code


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 or person

Institute

Hokuriku otolaryngology practiced expert study group

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2013 Year 11 Month 27 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name