UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031564
Receipt number 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 2023/04/13 09:07:33

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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 Takanori
Middle name
Last name Kanai

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3437

Email

takagast@z2.keio.jp


Public contact

Name of contact person

1st name Motohiko
Middle name
Last name Kato

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3437

Homepage URL


Email

moto28hiko@icloud.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Keio University School of Medicine

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.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

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

Main results already published

Date of protocol fixation

2018 Year 01 Month 22 Day

Date of IRB

2018 Year 02 Month 23 Day

Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2021 Year 01 Month 04 Day

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

2023 Year 04 Month 13 Day



Link to view the page

Value
https://center6.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