UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001124 |
|---|---|
| Receipt number | R000001359 |
| Scientific Title | Clinical Assessment to Establish the Symptomatic Advantage of Rabeprazole: double-blind, randomized, placebo-controlled study in functional dyspepsia |
| Date of disclosure of the study information | 2008/04/29 |
| Last modified on | 2010/10/07 11:06:09 |
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Basic information
Public title
Clinical Assessment to Establish the Symptomatic Advantage of Rabeprazole: double-blind, randomized, placebo-controlled study in functional dyspepsia
Acronym
CAESAR study
Scientific Title
Clinical Assessment to Establish the Symptomatic Advantage of Rabeprazole: double-blind, randomized, placebo-controlled study in functional dyspepsia
Scientific Title:Acronym
CAESAR study
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 rabeprazole in functional dyspepsia by double-blind, randomized, placebo-controlled trials
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of dyspeptic symptoms by Gastrointestinal Symptoms Rating Scale (GSRS)
Key secondary outcomes
Patients' Background
QOL evaluation by SF-8
Anti-H. pylori IgG
Serum pepsinogen I, pepsinogen II
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole
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
Patients with functional dyspepsia diagnosed according to the Rome III classification.
Key exclusion criteria
1. Organic disease such as reflux esophagitis (> grade A) and erosive gastritis.
2. Patients with past history of gastrectomy
3. NSAIDs or low-dose aspirin -related dyspepsia
4. Patients with organic disease in the brain or with psychological disorders
5. Patients with alcoholics or with drug dependence
6. Severe endocrine disease including hyperthyroidism
7. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases
8. Drug allegy for rabeprazole
9. expectant mother, mother with breast-feeding
10. other not applicable person recognized by a doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki, M.D., Ph.D. |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-5363-3914
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tomotsugu, Ph.D. |
Organization
Keio University School of Medicine
Division name
Center for Clinical Research
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
TEL
03-3353-1211
Homepage URL
naokit@sc.itc.keio.ac.jp
Sponsor or person
Institute
Office of CAESAR study
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Group for CAESAR study
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
| 2008 | Year | 04 | Month | 29 | 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
| 2008 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 21 | Day |
Last modified on
| 2010 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
