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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009208
Receipt No. R000010797
Scientific Title Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Date of disclosure of the study information 2012/10/29
Last modified on 2013/11/26

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Basic information
Public title Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Acronym Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Scientific Title Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Scientific Title:Acronym Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Region
Japan

Condition
Condition community acquired bacterial pneumonia and mycoplasma pneumonia
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the clinical efficacy and safety of CLARITH Tablets 200 mg (800mg/day) administration for the subjects with community acquired bacterial pneumonia and mycoplasma pneumonia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy:
A clinical response will be evaluated by an attending physician at the end of the medication or at the end of observation period.
Safety:
An adverse event will be recorded until the end of medication.
Key secondary outcomes Efficacy:
A bacterial response will be evaluated at the end of the medication or at the end of observation period.

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 CLARITH Tablets 200mg(800mg/day)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subject of this study are patients who fulfill all following criteria and need this drug treatment.
1)Patients whose JRS severity classification are mild to moderate.
2)Patients who can treat out of hospital refer to JRS guideline.
3)Patients whose presumable pathogenic bacteria is S.pneumoniae, H.influenzae or M.pneumoniae otherwise patients suspected to be bacterial pneumonia or Mycoplasma pneumonia by physician in charge.
Key exclusion criteria 1)Patients with known hypersensitivity to clarithromycin or any other component of the product.
2)Patients receiving treatment with pimozide, ergotamine(or its derivatives), or tadalafil/ADCIRCA.
3)Patients under 20 years old.
4)Patients with hypersensitivity to any other antibiotics.
5)Patients with hepatic dysfunction, renal impairment, cardiac disorder, or other severe complication which inadequate this study.
6)Women known pregnant, lactation or suspected to be pregnant.
7)Patients who are regarded as inadequate subject by physician in charge (*)
*Posible to enter the patients who treat low-dose long-time macrolides therapy(200mg) when increase the dosage(800mg).
*Posible to enter the patients who previously treat 400mg of clarithromycin if increase the dosage(800mg).
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Niki
Organization School of Medicine, Showa University
Division name Clinical Infectious Disease
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Fukuta
Organization Organization of Clinical Trials for Respiratory and Infectious Disease
Division name secretariat
Zip code
Address 23-16-2 Kaminakano, Kita-ku, Okayama-shi, Okayama 700-0972, Japan
TEL 086-805-8722
Homepage URL
Email fukuta@calo.co.jp

Sponsor
Institute Organization of Clinical Trials
for Respiratory and Infectious Disease
Institute
Department

Funding Source
Organization Organization of Clinical Trials
for Respiratory and Infectious Disease
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
2012 Year 10 Month 29 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
2012 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 26 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 29 Day
Last modified on
2013 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010797

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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