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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005543
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Graduate School of Medical and Dental Sciences Kagoshima University Pulmonary Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004825

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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