Unique ID issued by UMIN | UMIN000005943 |
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Receipt number | R000007023 |
Scientific Title | The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD) |
Date of disclosure of the study information | 2011/07/07 |
Last modified on | 2011/07/06 22:35:07 |
The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Japan |
Mild gastroesophageal reflux disease
Gastroenterology |
Others
NO
To investigate the efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Efficacy
Exploratory
Pragmatic
Phase II
Evaluation of GERD symptoms using Frequency Scale for the Symptoms of GERD (FSSG)
Record of symptoms
Frequency of heartburn during day and night
Evaluation of QOL using Face Scale
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Lafutidine
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with Grade N, M, A or B (Los Angeles classification) mild GERD
2) Patients with heartburn symptoms once or more a week
3) More than 20 years old Patients who agree to participate in the study on a written informed consent form
1) Patients with hypersensitivity for Lafutidine
2) Patients with serious liver abnormality
3) Patients who took gastric acid inhibitors such as proton pump inhibitor and H2 blocker within 1 week
4) Patients who taking medicine which interfere with the study
5) Patients with depression symptoms
6) Patients considered inappropriate by the study investigator
40
1st name | |
Middle name | |
Last name | Mikitaka Iguchi |
Wakayama Medical University
Internal Medicine (Second Department)
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
1st name | |
Middle name | |
Last name |
Wakayama Medical University
Internal Medicine (Second Department)
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
Wakayama Medical University
None
Self funding
NO
2011 | Year | 07 | Month | 07 | Day |
Unpublished
Open public recruiting
2011 | Year | 06 | Month | 17 | Day |
2011 | Year | 07 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2011 | Year | 07 | Month | 06 | Day |
2011 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007023
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