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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023886
Receipt No. 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

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Basic information
Public title The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Acronym The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Scientific Title The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Kazunari Murakami
Organization Oita university
Division name Department of Gastroenterology
Zip code
Address 1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Japan
TEL 097-586-6193
Email murakam@oita-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazuhiro Mizukami
Organization Oita university
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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