Unique ID issued by UMIN | UMIN000004743 |
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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 |
Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
Evaluation of early clinical efficacy of azithromycin SR in treatment of acute pharyngotonsillitis and acute rhinosinusitis
Japan |
Acute pharyngotonsillitis
Acute rhinosinusitis
Oto-rhino-laryngology |
Others
NO
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.
Efficacy
Clinical efficacy judged by the scoring system at Day 4
*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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
2 g dose of azithromycin SR formulation
16 | years-old | <= |
80 | years-old | > |
Male and Female
(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
(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
300
1st name | |
Middle name | |
Last name | Shinji Tamura |
Wakayama Medical University
Otolaryngology-Head and Neck Surgery
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
1st name | |
Middle name | |
Last name |
Wakayama-Okayama Otolaryngology Pharma
secretariat
woop@calo.co.jp
Wakayama-Okayama Otolaryngology Pharma
Wakayama-Okayama Otolaryngology Pharma
Non profit foundation
NO
2010 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2010 | Year | 10 | Month | 25 | Day |
2010 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 31 | Day |
2012 | Year | 08 | Month | 31 | Day |
2012 | Year | 09 | Month | 30 | Day |
2010 | Year | 12 | Month | 17 | Day |
2012 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005648
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