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Recruitment status Terminated
Unique ID issued by UMIN UMIN000014384
Receipt No. 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

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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
Email 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
Email fukuhara@fmu.ac.jp

Sponsor
Institute Department of Pulmonary Medicine,
Fukushima Medical University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016665

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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