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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
JPRN-UMIN000003357 |
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Date of registration:
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01/04/2010 |
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Primary sponsor: |
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Public title:
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Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
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Scientific title:
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Date of first enrolment:
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2010/04/01 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://www.umin.ac.jp/ctr/index.htm |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Countries of recruitment
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Japan
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Contacts
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Name:
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Akiyoshi Nishio
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Address:
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10-15 Fumizono-cho, Moriguchi, Osaka, Japan
Japan |
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Telephone:
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06-6992-1001 |
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Email:
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Affiliation:
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Department of Gastroenterology and Hepatology Takii Hospital, Kansai Medical University |
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Name:
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Akiyoshi Nishio
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Address:
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10-15 Fumizono-cho, Moriguchi, Osaka, Japan
Japan |
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Telephone:
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nishioa@takii.kmu.ac.jp |
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Email:
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nishioa@takii.kmu.ac.jp |
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Affiliation:
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Department of Gastroenterology and Hepatology Takii Hospital, Kansai Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: (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.
Exclusion criteria: (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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Reflux esophagitis
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Intervention(s)
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Changing of proton pump inhibitor from ransoprazole to omeprazole.
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Primary Outcome(s)
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Treatment effect of omeprazole for patients with reflux esophagitis who are refractory to treatment with ransoprazole.
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Source(s) of Monetary Support
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None
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