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

Email



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


Email



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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name