UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003077 |
|---|---|
| Receipt number | 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 | 2020/05/04 15:25:12 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003730
