UMIN-CTR Clinical Trial

Public title

A Double-blind Placebo Controlled Study of Mosapride citrate for Efficacy on
Symptom Improvement of Patients with Functional Dyspepsia.

Acronym

Efficacy Study of Mosapride for Functional Dyspepsia

Scientific Title

A Double-blind Placebo Controlled Study of Mosapride citrate for Efficacy on
Symptom Improvement of Patients with Functional Dyspepsia.

Scientific Title:Acronym

Efficacy Study of Mosapride for Functional Dyspepsia

Region

Japan

Condition

Functional dyspepsia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroto Miwa

Organization

Hyogo College of Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya City, Hyogo, Japan

TEL

0798-45-6665

Email

miwa-sec@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroto Miwa

Organization

Hyogo College of Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya City, Hyogo, Japan

TEL

0798-45-6665

Homepage URL

Email

miwa-sec@hyo-med.ac.jp

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Osaka Cancer Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

03

Month

21

Day

Date of IRB

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

Other related information

Registered date

2013

Year

04

Month

17

Day

Last modified on

2016

Year

05

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012304