UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003963 |
|---|---|
| Receipt number | R000004412 |
| Scientific Title | Study on the effect of a combination therapy of H2 receptor antagonist and 5-HT3 receptor antagonist for the treatment of dyspepsia with mild irritable bowel syndrome |
| Date of disclosure of the study information | 2010/07/28 |
| Last modified on | 2014/08/01 13:43:37 |
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Basic information
Public title
Study on the effect of a combination therapy of H2 receptor antagonist and 5-HT3 receptor antagonist for the treatment of dyspepsia with mild irritable bowel syndrome
Acronym
Effect of a combination therapy of H2RA and 5-HT3RA for the treatment of dyspepsia with IBS
Scientific Title
Study on the effect of a combination therapy of H2 receptor antagonist and 5-HT3 receptor antagonist for the treatment of dyspepsia with mild irritable bowel syndrome
Scientific Title:Acronym
Effect of a combination therapy of H2RA and 5-HT3RA for the treatment of dyspepsia with IBS
Region
| Japan |
Condition
Condition
Male dyspepsia with mildly diarrheal IBS
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of a combination therapy of H2 receptor antagonis famotidine and 5-HT3 receptor antagonist ramosetron with famotidine alone in the male patients with dyspepsia having mildly diarrheal IBS
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in total score of gastrointestinal symptom questionnaire, Izumo Scale
Key secondary outcomes
*Changes in subscale scores and summary scores of health related QOL SF-8
*Chnages in subscale scores of Izumo Scale
*Patient preference of treatment(famotidine alone or combination of famotidine and ramosetron) at the end of trial
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Famotidine-preceding group:
Famotidine(20mg/day)is administered to study patient for 4 weeks. After 4 weeks famotidine(20mg/day)+ramosetron(5ug/day)are administered for 4 weeks.
Interventions/Control_2
Famotidine-preceding group:
Famotidine(20mg/day)+ramosetron(5ug/day)are administered to study patient for 4 weeks. After 4 weeks famotidine(20mg/day)is administered for 4 weeks.
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Patient to whom the subscale score of pain, discomfort of regurgitation is 3 or more and score of diarrhea is 2 or more in Izumo Scale
2.Duration of dyspepsia is 4 weeks or more
3.Male
4.From 20 years old to less or equal to 70 year old
5.Patient who obtained written informed consent
Key exclusion criteria
1.Patient who has a history of hypersensitivity
2.Patient who has organic illness such as gastroduodenal ulcer, gastric cancer, intestinal cancer or imflammatory bowel disease
3.Patient with chronic constipation or constipated IBS
4.Patient who is currently receiving H2RA, PPI or drugs for IBS
5.Patient who has renal disorder
6.Patient who has cardiovascular diseases
7.Patient who has hepatic disorder
8.Patient who is pregnant nursing mom
9.Patient wit whome the physicina-in-charge considered inappropriate as a subject of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Faculty of Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6665
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Upper Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6665
Homepage URL
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2010 | Year | 07 | Month | 28 | 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
| 2010 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 28 | Day |
Last modified on
| 2014 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004412
