UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia
Title of the study (Brief title)	Efficacy of Acotiamide Hydrochloride on Gastrointestinal Motility of Patients with Functional Dyspepsia
Region	Japan

Condition
Condition	Functional Dyspepsia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of acotiamide hydrochloride on gastric accommodation emptying and QOL of functional dyspepsia patients with bothersome postprandial fullness and early satiation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gastric emptying (T1/2) and accommodation (%) by gastric scintigraphy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acotiamide Hydrochloride
Interventions/Control_2	Placebo
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Outpatients who are at least 20 years of age. 2. Patients with at least one of the following symptoms. -Bothersome postprandial fullness after eating a normal amount of food that occurs at least twice a week. -Unable to finish a normal amount of food due to early satiation at least twice a week. 3. Patients with symptom onset at least 6 months before the visit who meet the above criteria over the last 3 months. 4. Patients who undergo upper gastrointestinal endoscopy within 1 year from the visit and are found to have no organic diseases (malignant tumors, peptic ulcer, esophagitis, etc.) that are likely to cause upper abdominal symptoms.
Key exclusion criteria	1. Patients with conditions that are likely to cause upper abdominal symptoms such as malignant tumors, peptic ulcers and systemic diseases (neurological diseases including Parkinson's disease, metabolic diseases including diabetes, etc). 2. Patients with known causes of upper abdominal symptoms including excessive drinking, overeating, taking NSAIDs, and sever stress. 3. Patients with predominant GERD 4. Patients with predominant irritable bowel syndrome (IBS) 5. Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus.
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroto Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	+81-798-45-6665
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	Tadayuki Oshima
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	+81-798-45-6662
Homepage URL
Email	t-oshima@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	2014 Year 03 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 28 Day
Anticipated trial start date	2014 Year 03 Month 28 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27639387
Results
Other related information

Management information
Registered date	2014 Year 03 Month 28 Day
Last modified on	2017 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015743