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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003077
Receipt No. R000003730
Scientific Title Analysis of the improvement effect of the abdominal symptom by the proton pump inhibitor for patients recieved chemotherapy
Date of disclosure of the study information 2010/01/22
Last modified on 2010/01/22

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Basic information
Public title Analysis of the improvement effect of the abdominal symptom by the proton pump inhibitor for patients recieved chemotherapy
Acronym Effect of proton pump inhibitor for patients received chemotherapy
Scientific Title Analysis of the improvement effect of the abdominal symptom by the proton pump inhibitor for patients recieved chemotherapy
Scientific Title:Acronym Effect of proton pump inhibitor for patients received chemotherapy
Region
Japan

Condition
Condition Colon cancer patients received chemotherapy
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effect of proton pump inhibitor for the improvement of abdominal sympton in the colon cancer patients received chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Comparison of subjective symptom by a questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 omeprazole 10mg sid 4weeks
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who fills everything the following
1)Colon cancer patients received chemotherapy
2)Patients who gives written informed consent
3)Patients received upper endoscopy within 1 year.
Key exclusion criteria 1)Patients with peptic ulcers
2)Patients with severe GERD
3)Patients who has past history of allergy for the drugs used in this study
4)Patients with severe heart disease, liver disease,or renal disease
5)Pregnant females
6)Lacting woman
7)Patients who has past history of allergy for the drugs used in this study
4)Patients who has coexisting severe disease
5)Patient whom examination doctor judged improper as testee
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology
Institute
Department

Funding Source
Organization None
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
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
2010 Year 01 Month 22 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 22 Day
Last modified on
2010 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003730

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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