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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031564
Receipt No. R000036039
Scientific Title Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
Date of disclosure of the study information 2018/03/05
Last modified on 2018/09/03

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Basic information
Public title Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
Acronym P-CURE STUDY
Scientific Title Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
Scientific Title:Acronym P-CURE STUDY
Region
Japan

Condition
Condition early gastric cancer or gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the non-inferiority of 3 weeks treatment of
Bonopurazan for closure of artificial ulcer after gastric ESD compared to 8 weeks treatment of Bonopurazan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of complete closure of post ESD ulcer at 24 weeks after gastric ESD.
Key secondary outcomes 1) Proportion of bleeding within 3 weeks after gastric ESD.
2) Proportion of bleeding more than 3 weeks after gastric ESD.
3) Proportion of perforation within 3 weeks after gastric ESD.
4) Proportion of perforation more than 3 weeks after gastric ESD.
5) Proportion of complete closure of post ESD ulcer at 8 weeks after gastric ESD.
6) Status of post ESD ulcer (evaluated based on Sakita Miwa classification) at 8 and 24 weeks after ESD.
7) Medical care cost.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Included subjects take Bonoprazan 20mg per day for 21 days.
Interventions/Control_2 Included subjects take Bonoprazan 20mg per day for 56 days.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients aged 20-85 undergoing gastric ESD for early gastric cancer or gastric adenoma.
Key exclusion criteria 1) Patients with past history of surgery for upper GI tract.
2) Patients with eGFR<30 or on hemodialysis.
3) Patients with uncompensated liver cirrhosis.
4) Patients with severe bleeding tendency.
5) Patients taking systemic NSAIDs or steroid.
6) Patients taking anti-platelet or coagulant drugs.
7) Patients taking PPI or P-CAB continuously at the time of registry.
8) Patients with perforation during ESD.
9) Patients not fulfilling curative criteria by ESD.
10) Patients taking Atazanavir or Rirupibirin.
11) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Kanai
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiko Kato
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Homepage URL
Email moto28hiko@icloud.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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
2018 Year 03 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 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
2018 Year 03 Month 04 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036039

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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