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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002432
Receipt No. R000002953
Scientific Title Investigation of relationships among upper abdominal symptoms, findings of esophagogastroduodenoscopy (EGD) and quality of life (QOL) and comparing study of therapeutic effects of various gastrointestinal drugs on upper abdominal symptoms of patients with functional dyspepsia (FD) or non-errosive reflux disease (NERD) by using questionnaires to evaluate upper abdominal symptoms (GOS) and QOL (SF-8).
Date of disclosure of the study information 2009/09/15
Last modified on 2012/04/02

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Basic information
Public title Investigation of relationships among upper abdominal symptoms, findings of esophagogastroduodenoscopy (EGD) and quality of life (QOL) and comparing study of therapeutic effects of various gastrointestinal drugs on upper abdominal symptoms of patients with functional dyspepsia (FD) or non-errosive reflux disease (NERD) by using questionnaires to evaluate upper abdominal symptoms (GOS) and QOL (SF-8).
Acronym Evaluation of therapeutic effects of various gastrointestinal drugs on upper abdominal symptoms and QOL of patients with FD or NERD by GOS and SF-8 questionnaires.
Scientific Title Investigation of relationships among upper abdominal symptoms, findings of esophagogastroduodenoscopy (EGD) and quality of life (QOL) and comparing study of therapeutic effects of various gastrointestinal drugs on upper abdominal symptoms of patients with functional dyspepsia (FD) or non-errosive reflux disease (NERD) by using questionnaires to evaluate upper abdominal symptoms (GOS) and QOL (SF-8).
Scientific Title:Acronym Evaluation of therapeutic effects of various gastrointestinal drugs on upper abdominal symptoms and QOL of patients with FD or NERD by GOS and SF-8 questionnaires.
Region
Japan

Condition
Condition Functional dyspepsia (FD), Non-erosive reflux disease (NERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to investigate the relationships among upper abdominal symptoms and QOL, those are evaluated by questionnaires of GOS and SF-8 and findings of EGD in the examinees undergoing a work-up EGD as a part of a mass-screening program for gastric cancer, and to evaluate therapeutic effects of various gastrointestinal drugs administrated to upper abdominal symptoms of patients with FD
or NERD in clinical practice by investigating temporal improvement of scores of GOS and SF-8 questionnaires during their medication for 2 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in scores of GOS (Global Overrall Sverity) and SF-8 (iHope International) questionnaires prior to EGD, at 1 week and 2 weeks after medications
Key secondary outcomes 1)Findings of EGD
2)Urinary anti-Helicobacter pylori antibody

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Subjects with more than 4 points of GOS score at least one item and no organic disease certified by EGD are medicated with any of the following drugs 1) - 4) for 2weeks, and then answer the questionnaires of GOS and SF-8 at 1 week and 2 week after medication.

1) Rabeprazole (Pariet) 10mg once daily for 2 weeks
Interventions/Control_2 2) Famitidine (Gaster) 10mg twice daily for 2 weeks
Interventions/Control_3 3) Mosapride (Gasmotin) 5mg three times daily for 2 weeks
Interventions/Control_4 4) Teprenone (Selbex) 50 mg three times daily for 2 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who meet the following requirements 1) - 3) with their consents to participate in the present study are selected from the examinees undergoing a work-up EGD as a part of a mass-screening program for gastric cancer, who answer questionnaires of GOS and SF-8 prior to EGD;
1)GOS score show more than 4 points at least one item.
2)No organic disease is certified by EGD.
3)Patients desire to medicate their upper abdominal symptoms.
Key exclusion criteria 1)Examinees have organic diseases detected by EGD including peptic ulcer, malignant neoplasm, reflux esophagitis more than grade A of LA classification, etc.
2)Examinees undergoing forceps biopsy during EGD
3)examinees with a past history of Helicobacter pylori eradication therapy
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuaki Kato
Organization Miyagi Cancer Society
Division name Cancer Detection Center
Zip code
Address 5-7-30 Kamisugi, Aoba-ku, Sendai, Miyagi 980-0011, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Miyagi Cancer Society
Division name Cancer Detection Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Cancer Detection Center of Miyagi Cancer Society
Institute
Department

Funding Source
Organization Cancer Detection Center of Miyagi Cancer Society
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Gastroenterology, Tohoku University Hospital
Name of secondary funder(s) Division of Gastroenterology, Tohoku University Hospital

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
2009 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 02 Day
Last modified on
2012 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002953

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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