UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002056 |
|---|---|
| Receipt number | R000002502 |
| Scientific Title | Effects of rabeprazole on acute exacerbation in chronic obstructive pulmonary disease (COPD) patients with acid reflux symptoms |
| Date of disclosure of the study information | 2009/06/10 |
| Last modified on | 2012/10/29 17:12:47 |
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Basic information
Public title
Effects of rabeprazole on acute exacerbation in chronic obstructive pulmonary disease (COPD) patients with acid reflux symptoms
Acronym
Effects of rabeprazole on acute exacerbation in COPD patients with acid reflux symptoms
Scientific Title
Effects of rabeprazole on acute exacerbation in chronic obstructive pulmonary disease (COPD) patients with acid reflux symptoms
Scientific Title:Acronym
Effects of rabeprazole on acute exacerbation in COPD patients with acid reflux symptoms
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD), gastroesophageal reflux disease
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective study for inhibitory effects of proton pump inhibitor rabeprazole on acute exacerbation in COPD patients with acid reflux symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of acute exacerbation of chronic obstructive pulmonary disease in a year
Key secondary outcomes
Frequency of common cold in a year
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole 10mg per day for a year
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic obstructive pulmonary disease patients and gastroesophageal reflux diagnosed with QUEST questionnaire.
Key exclusion criteria
1.Patients treated with gastric secretion inhibitor in a month prior to this study.
2.Patients with active peptic ulcer or Zollinger-Ellison syndrome.
3.Patients with malignancy.
4.Patients with cardiac, hepatic or hematologic disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Diseiase
Zip code
Address
2-1 Seiryo-Machi, Aoba-ku, Sendai
TEL
022-717-7184
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Sasaki |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1 Seiryo-Machi, Aoba-ku, Sendai
TEL
022-717-8539
Homepage URL
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scholarship donation
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 08 | Day |
Last modified on
| 2012 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002502
