UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002432 |
|---|---|
| Receipt number | 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 16:43:55 |
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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
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
Sponsor or person
Institute
Cancer Detection Center of Miyagi Cancer Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002953
