UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002555
Receipt No. R000003121
Scientific Title Early effects of administrations of Roxatidine(H2RA) and Omeprazole(PPI) on intragastric pH
Date of disclosure of the study information 2009/09/30
Last modified on 2010/06/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Early effects of administrations of Roxatidine(H2RA) and Omeprazole(PPI) on intragastric pH
Acronym Early effects of administrations of H2RA and PPI on intragastric pH
Scientific Title Early effects of administrations of Roxatidine(H2RA) and Omeprazole(PPI) on intragastric pH
Scientific Title:Acronym Early effects of administrations of H2RA and PPI on intragastric pH
Region
Japan

Condition
Condition healty adult men
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The ideal medication for treatment of acid related diseases should have a rapid onset of action to promote hemostasis and symptoms.
Proton pump inhibitors is used for GERD and gastric ulcer etc.
The aim of our study was to investigate the inhibitory effects on gastric acid secretion after single administrations of Roxatidine 75mg and Omeprazole 20mg.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intragastric pH by pH meter attached to the antimony pH electrode
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Omeplazole 20mg
Interventions/Control_2 Roxatidine 75mg
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
Key inclusion criteria Patient who fills everything the following
1) Helicobacter pylori-negative male Patient
2) Patient of 20 years or more
3) Patient who gives written informed consent
Key exclusion criteria The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL 045-787-2640
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Inamori
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL 045-787-2640
Homepage URL
Email inamorim@med.yokohama-cu.ac.jp

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 横浜市立大学大学院(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 30 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
2009 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 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
2009 Year 09 Month 28 Day
Last modified on
2010 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.