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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010521
Receipt No. R000012304
Scientific Title A Double-blind Placebo Controlled Study of Mosapride citrate for Efficacy on Symptom Improvement of Patients with Functional Dyspepsia.
Date of disclosure of the study information 2013/04/18
Last modified on 2016/05/16

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Basic information
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
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

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

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
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

Public contact
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

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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)

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
2013 Year 04 Month 18 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
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
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

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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