UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017268 |
|---|---|
| Receipt number | R000020041 |
| Scientific Title | Treatment Reality with Patients' Treatment Response in RE patients treated with low dose of PPIs via Web-based survey |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/09/04 15:06:44 |
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Basic information
Public title
Treatment Reality with Patients' Treatment Response in RE patients treated with low dose of PPIs via Web-based survey
Acronym
The LILAC study
(Treatment reality of Low dose PPIs for refLux and ACid regurgitation)
Scientific Title
Treatment Reality with Patients' Treatment Response in RE patients treated with low dose of PPIs via Web-based survey
Scientific Title:Acronym
The LILAC study
(Treatment reality of Low dose PPIs for refLux and ACid regurgitation)
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the treatment response of RE patients treated with low dose of PPI
Basic objectives2
Others
Basic objectives -Others
the treatment response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of patient which all the item are selected to "1 day" or "nothing " of question 1,2,5,6 in GerdQ
Key secondary outcomes
The item raised below is estimated.
1. The GerdQ score
Mean of the whole questions of GerdQ
2. Healthy related QOL evaluation
Mean of the SF-8TM J core
3. Patient's sentiment to a disease and treatment
original questionnaire are which consiets of seven scale and enable to select more than two items at the same time.
4. The degree of the subjective symptom
Sevenity of the subjective symptom (heartburn, acid reflux, epigastralgia, belch, nausea, vomit, dysphagia, epigastric distress (stomach leaning) and inappetence)
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
1.Subjects aged 20 years or older at the time of providing informed consent.
2.Subjects with a diagnosis of reflux esophagitis by physician
3.Subjects who have been treated with low dose or PPI for at least 4 weeks to relief or maintain remission of heartburn and/or acid regurgitation
Key exclusion criteria
1.Subjects suspected of poor capability follow instructions of the survey.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AstraZeneca K.K. Gastrointestinal Medical |
Organization
AstraZeneca K.K.
Division name
Gastrointestinal Respiratory/Inflammation / Autoimmune Medical
Zip code
Address
Grand Front Osaka Tower B, 3-1,
TEL
+81-6-4802-3600
re-research@mebix.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Osawa |
Organization
Mebix, Inc.
Division name
Research Promotion
Zip code
Address
1-11-44 Akasaka, Minato-ku, Tokyo, 1070052, Japan
TEL
03-6229-8936
Homepage URL
re-research@mebix.co.jp
Sponsor or person
Institute
AstraZeneca K.K. Medical
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 24 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The proportion of patient which all the item are selected to "1 day" or "nothing " of question 1,2,5,6 in GerdQ
Management information
Registered date
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2015 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020041
