Unique ID issued by UMIN | UMIN000005772 |
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Receipt number | R000006821 |
Scientific Title | Clinical efficacy and safety of double dose (200 mg tid) CDTR-PI based on scoring system for adult acute pharyngotonsillitis |
Date of disclosure of the study information | 2011/07/01 |
Last modified on | 2012/03/26 20:14:08 |
Clinical efficacy and safety of double dose (200 mg tid) CDTR-PI based on scoring system for adult acute pharyngotonsillitis
Clinical efficacy of double dose CDTR-PI for adult acute pharyngotonsillitis
Clinical efficacy and safety of double dose (200 mg tid) CDTR-PI based on scoring system for adult acute pharyngotonsillitis
Clinical efficacy of double dose CDTR-PI for adult acute pharyngotonsillitis
Japan |
Adult pharyngitis and tonsillitis
Pneumology |
Others
NO
To evaluate the clinical efficacy and safety of double dose (200 mg tid) CDTR-PI for the treatment of sever and moderate cases in adult patients with acute pharyngotonsillitis.
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
Clinical efficacy
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
serious and medium patients of adult acute pharyngitis and tonsillitis are prescribed two tablet CDTR-PI 200mg at three times a day.Within seven days
16 | years-old | < |
Not applicable |
Male and Female
- Patients aged 16 years or over.
- Patients with severe or moderate acute pharyngotonsillitis based on acute pharyngotonsillitis scoring system
- Cases with definite improvement of symptoms or observations by previous treatment of other antibiotics within 7 days before administration.
- Cases of atypical infection caused by bacteria out of indication (eg. mycoplasma, chlamydia).
- Cases with serious or progressive underlying disease/complication, hard to evaluate efficacy and safety.
- Cases with severe renal function disorder (Ccr < 30 mL/min and/or on hemodialysis)
- Cases with a history of hypersensitivity for cephalosporins and/or penicillins
- Cases with concomitant use of other antibiotics (excluding the long-term, low dose macrolides therapy)
- Other cases which doctor in charge decide that the patient is not suitable for the study
100
1st name | |
Middle name | |
Last name | shin kawahara |
kawahara medical clinic
kawahara medical clinic
3317-1 hayashima hayashima-chou tukubo okayama 701-0304 japan
086-480-1112
1st name | |
Middle name | |
Last name | shin kawahara |
kawahara medical clinic
kawahara medical clinic
3317-1 hayashima hayashima-chou tukubo okayama 701-0304 japan
086-480-1112
kawashin@abeam.ocn.ne.jp
research association of okayama clinican
none
Self funding
Japan
NO
2011 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
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2011 | Year | 06 | Month | 13 | Day |
2012 | Year | 03 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006821
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