UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004743
Receipt number R000005648
Scientific Title Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
Date of disclosure of the study information 2010/12/18
Last modified on 2012/10/26 15:45:01

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Basic information

Public title

Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis

Acronym

Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis

Scientific Title

Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis

Scientific Title:Acronym

Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis

Region

Japan


Condition

Condition

Acute pharyngotonsillitis
Acute rhinosinusitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objective of this study is to evaluate the clinical efficacy of 2 g dose of azithromycin SR formulation using the clinical scoring system in treatment of patients with acute pharyngotonsillitis or acute rhinosinusitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical efficacy judged by the scoring system at Day 4

Key secondary outcomes

*Clinical efficacy judged by the scoring system at Day 8
*Bacteriological efficacy
*Change of clinical symptoms on the patients' diary
*Antipyretic rate(<37.0) at day4 and day8
*Improvement rate of each symptom at day4 and day8
*Clinical efficacy judged by investigators
*Recurrence rate at day15


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

2 g dose of azithromycin SR formulation

Interventions/Control_2


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

16 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

(1) 16 years or older
(2) Acute pharyngotonsillitis (peritonsillitis, peritonsillar abscess), or acute rhinosinusitis.(see Diagnostic criteria)
(3)Diagnosed as moderate or severe in the clinical severity
(4)Written informed consent of the subject or a legally authorized representative.

Diagnostic criteria
Acute pharyngotonsillitis
(a) Sore throat and/or swallowing pain
(b)Redness or swelling of pharyngeal and/or tonsillar mucosa
(c) Cryptic plugs and purulent discharge on pharynx and/or tonsils

Acute rhinosinusitis
(a)Purulent or mucopurulent rhinorrhea or postnasal drip
(b)Facial pressure or facial pain / Frontal headache

Key exclusion criteria

(1)Patients with known or suspected hypersensitivity or intolerance to azithromycin, or other macrolides
(2)Patients who require additional systemic antibiotic therapy
(3)Pregnant or lactating women
(4)Patients who have a history of severe heart diseases
(5)Hepatic dysfunction (AST, ALT, total bilirubin > 5 times institutional normal value)
(6)Severe renal dysfunction ( serum creatinine > 2.0 mg/dL)
(7)Severe underlying disease; patients in which clinical evaluation is difficult because of confounding diseases. (e.g., collagen disease, leukemia, advanced cancer etc.)
(8)Patients required to have fobidden concomitant medication or treatment
(9)Patients showing improvement of symptoms by the other antibiotic therapy
(10) Administration of azithromycin ER 7 days before starting azithromycin SR
(11) Patients with any gasrtointestinal disturbances that might affect drug absorption
(12)Patients with inability or unwillingness to swallow suspension
(13)For other reasons, patients determined to be inappropriate for study entry by investigator.

Acute pharyngotonsillitis
(14)Patients with history of rheumatic fever

Acute rhinosinusitis
(15) Patients who have had nasal/paranasal sinus surgeris within 3 months prior to the study (except diagnostic surgical procedures)
(16)Complicated sinusitis (e.g. osteomyelitis, Pott's puffy tumor, or malignant sinus diseases)
(17)Nosocomial sinusitis

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Tamura

Organization

Wakayama Medical University

Division name

Otolaryngology-Head and Neck Surgery

Zip code


Address

811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Wakayama-Okayama Otolaryngology Pharma

Division name

secretariat

Zip code


Address


TEL


Homepage URL


Email

woop@calo.co.jp


Sponsor or person

Institute

Wakayama-Okayama Otolaryngology Pharma

Institute

Department

Personal name



Funding Source

Organization

Wakayama-Okayama Otolaryngology Pharma

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 18 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

2010 Year 10 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2012 Year 08 Month 31 Day

Date analysis concluded

2012 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 17 Day

Last modified on

2012 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name