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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004743
Receipt No. 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

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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
Institute Wakayama-Okayama Otolaryngology Pharma
Institute
Department

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
URL(English) https://upload.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


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