UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028836
Receipt No. 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 (Ver. 6)

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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
Email 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
Email sakatay@cc.saga-u.ac.jp

Sponsor
Institute Saga Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033004