UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008534 |
|---|---|
| Receipt number | R000009948 |
| Scientific Title | A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease. |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2014/10/21 16:54:29 |
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Basic information
Public title
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.
Acronym
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.
Scientific Title
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.
Scientific Title:Acronym
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.
Region
| Japan |
Condition
Condition
Patients with expectoration symptom in acute exacerbation of bronchial asthma or chronic obstructive pulmonary disease.
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of EMPYNASE P Tablets with placebo in acute exacerbation patients with expectoration of bronchial asthma or chronic obstructive pulmonary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Changing rate of FEV1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EMPYNASE group
EMPYNASE P Tablets are administrated orally after three meals for 2 weeks.
Interventions/Control_2
Placebo group
Placebos are administrated orally after three meals for 2 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Patients with asthma or COPD.
-Patients who can be seen in outpatient department.
-Patients who can be looked at historical data of FEV1 in stable condition.
-50% <= %FEV1 < 80%.
-Patients who has expectorate symptoms defined in this study.
-Patients who can expectorate sputum by oneself.
Key exclusion criteria
-Patients with a history of drug hypersensitivity.
-Patients with blood clotting defect.
-Elderly patients with depressed physiological function and who are judged to be inadequate to participate in this trial by the principal investigator or co-investigator.
-Patients who are needed domiciliary oxygen therapy.
-Patients whose general status are quite worsened.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Takahashi |
Organization
Kaken Pharmaceutical Co., LTD.
Division name
Clinical Development Department
Zip code
Address
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-5977-5111
takahashi_akira@kaken.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminori Kobayashi |
Organization
Kaken Pharmaceutical Co., LTD.
Division name
Clinical Development Department
Zip code
Address
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-5977-5111
Homepage URL
kobayashi_fuminori@kaken.co.jp
Sponsor or person
Institute
Kaken Pharmaceutical Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Kaken Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | Month | 25 | 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 | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 14 | 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 | 07 | Month | 25 | Day |
Last modified on
| 2014 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
