Unique ID issued by UMIN | UMIN000023886 |
---|---|
Receipt number | R000027482 |
Scientific Title | The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study- |
Date of disclosure of the study information | 2016/09/01 |
Last modified on | 2018/02/22 17:19:32 |
The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Japan |
Functional dyspepsia
Helicobacter pylori infection
Gastroenterology |
Others
NO
To examine influence of the urase activity by H. pylori on acotiamide hydrochloride hydrate
Efficacy
The change of urea breath test by taking acotiamide hydrochloride hydrate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Other |
bacteriostatic of H. pylori by acotiamide hydrochloride hydrate
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1) The patients that suffer from fullness after meal, fullness at epigastrium or early satiety for more than one month
(2) In F scale, the score about Postprandial Distress Syndrome (PDS) is more than three points (The frequency of the symptom is more often).
(3) the patients who examined esophagogastroduodenography in the past 6 months and have no organic disease in stomach.
(4) Helicobacter pylori positive
(5) Patients who are older than 20 years old and less than 80 years old.
(6) Outpatients
(7) Patients from whom written informed consent is obtained.
(1) Chief complain is heartburn or epigastric pain
(2) The patients who have recieved the treatment of irritable bowel syndrome.
(3) The patients who have taken proton pump inhibitor, antibacterial agent, antiprotozoal agent, bismuth preparation, or ecabet sodium in the past 2 weeks.
(4) Severe drug allergy
(5) The pregnant, the lactating woman, or the patient hoping pregnancy.
(6) acotiamide allergy
(7) Patients who are judged as being inappropriate for this study by their medical doctor
30
1st name | |
Middle name | |
Last name | Kazunari Murakami |
Oita university
Department of Gastroenterology
1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Japan
097-586-6193
murakam@oita-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Mizukami |
Oita university
Department of Gastroenterology
1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita, Japan
097-586-6193
mizkaz0809@oita-u.ac.jp
Oita university
Astellas Pharma Inc., and Zeria Pharmaceutical Co., Ltd.
Other
Takada Chuo Hospital
NO
2016 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 23 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 09 | Month | 01 | Day |
2018 | Year | 02 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027482
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |