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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013544
Receipt No. R000015743
Scientific Title A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia
Date of disclosure of the study information 2014/03/28
Last modified on 2017/01/12

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Basic information
Public title A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia
Acronym Efficacy of Acotiamide Hydrochloride on Gastrointestinal Motility of Patients with Functional Dyspepsia
Scientific Title A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Tadayuki Oshima
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
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)

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
2014 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27639387
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
2014 Year 03 Month 28 Day
Date of IRB
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

Other
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

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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