Unique ID issued by UMIN | UMIN000003357 |
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Receipt number | R000004033 |
Scientific Title | Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration. |
Date of disclosure of the study information | 2010/04/01 |
Last modified on | 2010/03/19 15:05:33 |
Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
Study on treatment for patients with refractory reflux esophagitis with proton pump inhibitors.
Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
Study on treatment for patients with refractory reflux esophagitis with proton pump inhibitors.
Japan |
Reflux esophagitis
Gastroenterology |
Others
NO
Therapeutic effect by changing of a proton pump inhibitor to another for patients with refractory reflux esophagitis.
Efficacy
Treatment effect of omeprazole for patients with reflux esophagitis who are refractory to treatment with ransoprazole.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
Changing of proton pump inhibitor from ransoprazole to omeprazole.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients who can give a written consent to the entry of the study.
(2) Patients of 20 years old and over without distinction of gender.
(3) Patients who were diagnosed as having reflux esophagitis (Grade M to D).
(4) Patients who are taking ransoprazole 15mg or 30mg per day for more than 2 months.
(5) Patients whose symptoms are more than 8 points by F scale evaluation.
(1) Patients who are under 20 years of age.
(2) Patients who are allergic to the ingredient of the test drugs.
(3) Patients who underwent an operation of intestinal resection or vagotomy.
(4) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid body weight loss.
(5). Patients who had previous medical history of or suffer from the following diseases:Zollinger-Ellison syndrome, inflammatory bowel disease, irritable bowel disease, esophageal stenosis, esophageal achalasia, malabsorption, cerebrovascular disease such as cerebral hemorrhage, cerebral infarction.
(6) Patient who can not participate the study due to the coexistence of the diseases such as severe liver, renal or heart diseases.
(7) Patients who have malignancy or suspected malignancy (Cured patients are eligible).
(8) Patients who are pregnant, in breast-feeding, or may be pregnant.
(9) Patients who need continuous medication with drugs that are contraindication or dangerous to the combination with the test drug.
(10) Patients who take proton pump inhibitors except ransoprazole.
(11) Patients who take drugs that may affect the evaluation of the test drug (Patients who take such drugs without changing the usage or doses during the study period are eligible).
(12) Patients who are not considered to be eligible for the study by the doctor's judgment.
60
1st name | |
Middle name | |
Last name | Akiyoshi Nishio |
Department of Gastroenterology and Hepatology
Takii Hospital, Kansai Medical University
10-15 Fumizono-cho, Moriguchi, Osaka, Japa
06-6992-1001
1st name | |
Middle name | |
Last name | Akiyoshi Nishio |
Department of Gastroenterology and Hepatology
Takii Hospital, Kansai Medical University
10-15 Fumizono-cho, Moriguchi, Osaka, Japan
06-6992-1001
Department of Gastroenterology and Hepatology, Kansai Medical University
None
Self funding
NO
2010 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2009 | Year | 12 | Month | 03 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 03 | Month | 19 | Day |
2010 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004033
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