UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021282
Receipt number R000024547
Scientific Title Development of a Symptom Scale of Gastroesophageal Reflux Disease (GERD)
Date of disclosure of the study information 2016/03/02
Last modified on 2019/02/26 12:00:23

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Basic information

Public title

Development of a Symptom Scale of Gastroesophageal Reflux Disease (GERD)

Acronym

GERD symptom scale study

Scientific Title

Development of a Symptom Scale of Gastroesophageal Reflux Disease (GERD)

Scientific Title:Acronym

GERD symptom scale study

Region

Japan


Condition

Condition

Gastroesophageal Reflux Disease (GERD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a symptom scale by self-assessment questionnaire to assess the improvement of GERD symptoms by proton pump inhibitors

Basic objectives2

Others

Basic objectives -Others

Development of a symptom scale

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Reliability/validity/ responsiveness to treatment of the symptom scale for GERD developed in this study

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

I. [Common to Steps 1 to 3]
1. Patients who have been diagnosed with GERD (including reflux esophagitis and non-erosive gastroesophageal reflux disease) during routine medical care and have GERD symptoms
2. Male or female and is aged 20 years or older at the time of informed consent
II. [Step 1] Qualitative study (individual or group interview)
3. Patients capable of understanding the questions of the research team member or examiner and those capable of verbally explaining their own symptoms.
III. [Steps 2 and 3]
4. Patients with untreated gastroesophageal reflux disease and are planning to undergo treatment with a proton pump inhibitor

Key exclusion criteria

1.Patients strongly suspected of having ischemic heart disease
2.Patients strongly suspected of having asthma or chronic cough
3.Patients with obvious cognitive dysfunction that would affect the research

Target sample size

440


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Onishi, pHD.

Organization

Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)

Division name

iHope Research

Zip code


Address

Kyoto Daiichi Seimei Izumiya Bldg 7F, 513 Akinonocho, Karasuma-dori 2-jo sagaru, Nakagyo-ku, Kyoto, Japan 604-0847

TEL

075-211-5656

Email

onishi@i-hope.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Onishi,phD.

Organization

iHope International

Division name

iHope Research

Zip code


Address

Kyoto Daiichi Seimei Izumiya Bldg 7F, 513 Akinonocho, Karasuma-dori 2-jo sagaru, Nakagyo-ku, Kyoto,

TEL

075-211-5656

Homepage URL


Email

research@i-hope.jp


Sponsor or person

Institute

Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)

Institute

Department

Personal name



Funding Source

Organization

Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

京都第一赤十字病院 Japanese Red Cross Kyoto Daiichi Hospital
高槻赤十字病院 Takatsuki Red Cross Hospital
兵庫医科大学病院 The Hospital of Hyogo College of Medicine


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 02 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

Preinitiation

Date of protocol fixation

2016 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a multicenter, non-invasive, non-interventional clinical study to develop a GERD symptom scale by the following three steps:
Step1 Qualitative study: An anonymous self-assessment questionnaire on GERD symptoms will be completed by GERD patients. In addition, an individual or group interview will be performed under the following themes: Subjective symptoms of GERD, including severity, frequency, and onset condition and the associated obstacles, etc. in daily life, and the past therapeutic effect, change in GERD symptoms after treatment. Subjects remarks will be recorded and organized, and concepts and words representing GERD symptoms will be extracted. Based on these results, a preliminary version of the questionnaire containing a number of items will be prepared.
Step2 Pilot study: A different set of GERD patients will be asked to respond to the preliminary version of the questionnaire prepared in the preceding step. They will then be asked for feedback on comprehension of the questionnaire items and ease of answering questions. Responses will be aggregated and their distribution will be confirmed. Based on these results, questionnaire items will be refined and the development version of the questionnaire will be created.
Step3 Development study: A completely new [and independent] set of GERD patients will be asked to complete the questionnaire prepared in the preceding step.
Item analysis, determination of factor structure, selection of questionnaire items, and assessment of reliability/validity will be performed on the results of the responses taken before treatment. The mean change in the scale scores before and after treatment will be analyzed and assessment of the treatment response will be performed. Based on these results, a symptom scale as a questionnaire consisting of a small number of questionnaire items will be prepared.


Management information

Registered date

2016 Year 03 Month 02 Day

Last modified on

2019 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name