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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000005543 |
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Date of registration:
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09/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The double blind study of the clinical effects of anti-cholinergic agent "imidafenadcin" for COPD patients.
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Scientific title:
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The double blind study of the clinical effects of anti-cholinergic agent "imidafenadcin" for COPD patients. - The effects of imidafenacin for COPD. |
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Date of first enrolment:
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2011/03/01 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004825 |
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Study type:
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Interventional |
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Study design:
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Cross-over Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Ikkou higashimoto |
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Address:
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8-35-1 Sakuragaoka Kagoshima Japan
Japan |
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Telephone:
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099-275-6481 |
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Email:
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Affiliation:
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Graduate School of Medical and Dental Sciences Kagoshima University Pulmonary Medicine |
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Name:
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Hiromasa Inoue |
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Address:
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8-35-1 Sakuragaoka Kagoshima Japan
Japan |
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Telephone:
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099-275-6481 |
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Email:
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Affiliation:
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Graduate School of Medical and Dental Sciences Kagoshima University Pulmonary Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
40years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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COPD Chronic obstructive pulmonary disease
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Intervention(s)
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Patients receive a single dose of Imidafenacin0.1mg, and then washout 7-14 days, patients receive a placebo.
Patients receive a placebo, and then washout 7-14 day, patients receive a single dose of Imidafenacin0.1mg.
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Primary Outcome(s)
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pulmonary function test
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/12/2011 |
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URL:
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