UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014384 |
|---|---|
| Receipt number | R000016665 |
| Scientific Title | Efficacy of antitussive drug (codeine phosphate) on cough patients evaluated by cough monitor |
| Date of disclosure of the study information | 2014/10/15 |
| Last modified on | 2019/07/08 11:14:21 |
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Basic information
Public title
Efficacy of antitussive drug (codeine phosphate) on cough patients evaluated by cough monitor
Acronym
Efficacy of antitussive drug evaluated by cough monitor
Scientific Title
Efficacy of antitussive drug (codeine phosphate) on cough patients evaluated by cough monitor
Scientific Title:Acronym
Efficacy of antitussive drug evaluated by cough monitor
Region
| Japan |
Condition
Condition
cough patients
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of antitussive drug (codeine phosphate) commercially available
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of cough events before and after treatment of antitussive drug (codeine phosphate)
Key secondary outcomes
Cough VAS, LCQ (Leicester cough questionnaire), and capsaicin cough sensitivity test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
codeine phosphate 1% group
Interventions/Control_2
placebo group
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cough patients attending at the Department of Pulmonary Medicine, Fukushima Medical University Hospital
Key exclusion criteria
Infectious disease
Treatment-free asthma and COPD
Pregnant women or breast feeding women
Patients who are unable to give informed consent.
Inappropriate patients judged by respiratory physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsuro |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
9601247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1360
fukuhara@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Atsuro |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
9601247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1360
Homepage URL
fukuhara@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine,
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine,
Fukushima Medical University School of Medicine
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
Department of Pulmonary Medicine, Fukushima Medical University School of Medicine
Address
1 Hikarigaoka, Fukushima
Tel
024-547-1360
fukuhara@fmu.ac.jp
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
福島県立医科大学附属病院(福島県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016665
| 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 |
