UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005543 |
|---|---|
| Receipt number | R000004825 |
| Scientific Title | The double blind study of the clinical effects of anti-cholinergic agent "imidafenadcin" for COPD patients. |
| Date of disclosure of the study information | 2011/05/09 |
| Last modified on | 2012/05/01 19:38:33 |
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Basic information
Public title
The double blind study of the clinical effects of anti-cholinergic agent "imidafenadcin" for COPD patients.
Acronym
The effects of imidafenacin for COPD.
Scientific Title
The double blind study of the clinical effects of anti-cholinergic agent "imidafenadcin" for COPD patients.
Scientific Title:Acronym
The effects of imidafenacin for COPD.
Region
| Japan |
Condition
Condition
COPD Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of clinical efficts and safety of imidafenacin, an anti-cholinergic agent for COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pulmonary function test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive a single dose of Imidafenacin0.1mg, and then washout 7-14 days, patients receive a placebo.
Interventions/Control_2
Patients receive a placebo, and then washout 7-14 day, patients receive a single dose of Imidafenacin0.1mg.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female Japanese patients aged 40 years or older with clinically diagnosed stable COPD.
FEV1.0/FVC<0.70
It does not matter for the stage of a disease.
A smoking history more than 10 pack years.
The patient who can acquire a document agreement from the person himself.
Key exclusion criteria
Patients were excluded from participation if they corresponds to a contraindicated matter of imidafenacin(urinary retention, bowel obstruction, paralytic ileus, glaucoma, myasthenica gravis).
The patient who is complicated with chronic respiratory desease except COPD.
Patient having allergy to anticholinergic agent.
The patient who has difficulty perform of the spirometry.
In addition, the patient who judged that the examination medical attendant was inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Inoue |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Pulmonary Medicine
Zip code
Address
8-35-1 Sakuragaoka Kagoshima Japan
TEL
099-275-6481
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikkou higashimoto |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Pulmonary Medicine
Zip code
Address
8-35-1 Sakuragaoka Kagoshima Japan
TEL
099-275-6481
Homepage URL
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences Kagoshima University Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 02 | Day |
Last modified on
| 2012 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004825
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
