UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2009 Year 10 Month 05 Day
Date of IRB	2009 Year 10 Month 05 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 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 01 Month 22 Day
Last modified on	2020 Year 05 Month 04 Day

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