UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003837 |
|---|---|
| Receipt number | R000004623 |
| Scientific Title | Comparison of effects of rabeprazole sodium SAWAI 10 mg and Pariet 10mg tablets on acid secretion using 24-hour gastric pH monitoring |
| Date of disclosure of the study information | 2010/06/29 |
| Last modified on | 2011/12/30 15:25:14 |
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Basic information
Public title
Comparison of effects of rabeprazole sodium SAWAI 10 mg and Pariet
10mg tablets on acid secretion using 24-hour gastric pH monitoring
Acronym
Comparison of rabeprazole sodium SAWAI 10 mg and pariet tablets by gastric pH monitoring
Scientific Title
Comparison of effects of rabeprazole sodium SAWAI 10 mg and Pariet
10mg tablets on acid secretion using 24-hour gastric pH monitoring
Scientific Title:Acronym
Comparison of rabeprazole sodium SAWAI 10 mg and pariet tablets by gastric pH monitoring
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Rabeprazole sodium SAWAI 10 mg and pariet 10mg tablets pH in the stomach of 24 hours is monitored for a Japanese healthy man applicant so that it may make comparative study of the pH in the stomach of the lock 10mg.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
24-hour gastric pH monitoring data.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group: Execution on June 30. End August 5 in day
Interventions/Control_2
B group: Execution on July 2. End August 7 in day
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Japanese healthy male volunteers with ages of 20-35 years
2. Body weight 55-85 kg
3. BMI(body mass index) of 18.5- 25.0 (less than 25.0)
4 Nonsmoker or ex-smoker
5 H.pylori IgG antibody negative
Key exclusion criteria
1. History of major gut operations.
2. Hypersensitivity, allergy, and idiosyncrasy, to drugs
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Hukushima |
Organization
Tokyo-Eki Center-building Clinic
Division name
Medicine Offices
Zip code
Address
3-3-14 Nihonbashi, Chuo-ku,Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo-Eki Center-building Clinic
Division name
Medicine Offices
Zip code
Address
TEL
03-3517-6688
Homepage URL
Sponsor or person
Institute
Tokyo-Eki Center-building Clinic
Institute
Department
Personal name
Funding Source
Organization
Sawai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2010 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 28 | Day |
Last modified on
| 2011 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004623
