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
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
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
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
