UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Double-blind Placebo Controlled Study of Mosapride citrate for Efficacy on Symptom Improvement of Patients with Functional Dyspepsia.
Title of the study (Brief title)	Efficacy Study of Mosapride for Functional Dyspepsia
Region	Japan

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

Objectives
Narrative objectives1	To compare the improvement of upper abdominal symptoms and QOL and safety of Mosapride versus placebo by double-blind trial in patients with chronic gastritis experiencing "heavy stomach feeling" and "early satiety" in Japan with the aim of evaluating suitable therapeutic drugs for chronic heavy stomach feeling and early satiety, two gastric symptoms frequently found in Japanese.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Score for overall treatment efficacy (OTE) after 4 weeks of treatment with the study drug Response rate
Key secondary outcomes	Changes in OTE score Changes in response rate Evaluation scores by symptoms Disappearance rate of each symptom Disappearance rate of all symptoms SF-8 score Incidence of adverse events/adverse effects

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Two tablets of the study drug (Masapride) taken orally three times a day before meals for 4 weeks (a total of 168 tablets)
Interventions/Control_2	Two tablets of the reference drug (placebo) taken orally three times a day before meals for 4 weeks (a total of 168 tablets)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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. -Painful heavy feeling in the stomach 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 satiety at least twice a week. 3. Patients with symptom onset at least 6 months before the visit who meet the above criteria 2 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. 5. Patients who are not receiving the following drugs or patients who can have a washout period of the drugs for at least 2 weeks before administration of the study drug if they are receiving the drugs: prokinetic agents, gastric acid secretion inhibitors (H2-receptor antagonists, proton-pump inhibitors), gastric coating agents, prostaglandin preparations, antidepressants, anti-anxiety agents, sleep-inducing drugs, antipsychotic drugs 6. Patients who are willing to comply with medication instructions. 7. Patients who can understand the requirements of the study and provide written informed consent to participate.
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. 6. Patients with severe hepatic dysfunction or renal dysfunction. 7. Patients with confirmed or suspected mental disorders. 8. Women who are pregnant or who wish to be pregnant during the study period, and lactating mother. 9. Other patients whom the investigator deems unsuitable for the study. 10. Patients who received H. pylori eradication therapy within 6 months from the visit or patients who are receiving the eradication therapy.
Target sample size	200

Research contact person
Name of lead principal investigator	Hiroto Miwa
Organization	Hyogo College of Medicine
Division name	Department of Gastroenterology
Address	1-1, Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6665
Email	miwa-sec@hyo-med.ac.jp

Public contact
Name of contact person	Hiroto Miwa
Organization	Hyogo College of Medicine
Division name	Department of Gastroenterology
Address	1-1, Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6665
Homepage URL
Email	miwa-sec@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka Cancer Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2013 Year 04 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 21 Day
Anticipated trial start date	2013 Year 05 Month 07 Day
Last follow-up date	2015 Year 09 Month 30 Day
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	2013 Year 04 Month 17 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012304