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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001124
Receipt No. 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

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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
Email

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
Email naokit@sc.itc.keio.ac.jp

Sponsor
Institute Office of CAESAR study
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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