UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Title of the study (Brief title)	The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Region	Japan

Condition
Condition	Functional dyspepsia Helicobacter pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine influence of the urase activity by H. pylori on acotiamide hydrochloride hydrate
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of urea breath test by taking acotiamide hydrochloride hydrate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	bacteriostatic of H. pylori by acotiamide hydrochloride hydrate
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(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.
Key exclusion criteria	(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
Target sample size	30

Research contact person
Name of lead principal investigator	Kazunari Murakami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Japan
TEL	097-586-6193
Email	murakam@oita-u.ac.jp

Public contact
Name of contact person	Kazuhiro Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita, Japan
TEL	097-586-6193
Homepage URL
Email	mizkaz0809@oita-u.ac.jp

Sponsor
Institute	Oita university
Institute
Department

Funding Source
Organization	Astellas Pharma Inc., and Zeria Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Takada Chuo Hospital
Name of secondary funｄer(s)

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	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 01 Day
Last modified on	2018 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027482