UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028836 |
|---|---|
| Receipt number | R000033004 |
| Scientific Title | A Study on the Status of Proton Pump Inhibitor Prescriptions Using DPC Data |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2019/09/06 16:57:12 |
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Basic information
Public title
A Study on the Status of Proton Pump Inhibitor Prescriptions Using DPC Data
Acronym
Status of Proton Pump Inhibitor Prescriptions
Scientific Title
A Study on the Status of Proton Pump Inhibitor Prescriptions Using DPC Data
Scientific Title:Acronym
Status of Proton Pump Inhibitor Prescriptions
Region
| Japan |
Condition
Condition
Peptic ulcer Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the status of PPI use in hospitalized patients
Basic objectives2
Others
Basic objectives -Others
To clarify the status of PPI use in hospitalized patients by analyzing the PPI prescription data for the past 8 years using the "DPC survey data" of approximately ten thousand patients a year in Saga University.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the trend of number of hospitalized patients who were prescribed PPI for the past 8 years.
Key secondary outcomes
To clarify the changes in the characteristics of PPI prescribed patients (age, indication, concomitant medication, co-morbidity, and clinical department that follows a patient) on an inpatient basis for the past 8 years.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Survey period: 1 Jan 2009 to 31 Dec 2016
Patients who were treated at this hospital on an inpatient basis during the survey period above and prescribed PPI.
Key exclusion criteria
None
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | YASUHISA |
| Middle name | |
| Last name | SAKATA |
Organization
Saga Medical School
Division name
Internal Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952342361
sakatay@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | YASUHISA |
| Middle name | |
| Last name | SAKATA |
Organization
Saga Medical School
Division name
Internal Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952342361
Homepage URL
sakatay@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Medical School
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
Saga Medical School, clinical research center
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
e6035@cc.saga-u.ac.jp
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
| 2017 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30840949
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30840949
Number of participants that the trial has enrolled
11009
Results
PPI prescription proportions significantly increased over the study period. The use of PPIs increased steadily with increasing age.In most clinical departments, the number of patients prescribed PPIs was up to 3 times higher in the second half of the period (2013-2016) compared with the first half of the period (2009-2012). The number of patients taking concomitant PPIs and anticoagulants or dual antithrombotic combination therapy increased.
Results date posted
| 2019 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 06 | Day |
Baseline Characteristics
We analyzed PPI prescription data for the past 8 years (2009-2016) using Diagnosis Procedure Combination survey data from approximately 10,000 patients per year at Saga University Hospital.
Participant flow
A retrospective observational study was performed.
Adverse events
None
Outcome measures
We investigated the trend in the number of hospitalized patients who were prescribed PPI for the past 8 years and the changes in patient characteristics.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
1. The trend of the number of patients who were prescribed PPI for the past 8 years.
2. Changes in characteristics of patients (age, indication, concomitant medication, co-morbidity, and clinical department that follows a patient) who were prescribed PPI for the past 8 years.
(List of proton pump inhibitors subjected to the survey)
Omeprazole 10 mg / 20 mg, esomeprazole 10 mg / 20 mg, lansoprazole 15 mg / 20 mg, rabeprazole 5 mg / 10 mg / 20 mg, vonoprazan 10 mg / 20 mg
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033004
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