UMIN-CTR Clinical Trial

Public title

Cure of H. pylori infection for Early Age Patients study

Acronym

Cure of H. pylori infection for Early Age Patients study(CHEAP study)

Scientific Title

Cure of H. pylori infection for Early Age Patients study

Scientific Title:Acronym

Cure of H. pylori infection for Early Age Patients study(CHEAP study)

Region

Japan

Condition

Helicobacter pylori infection

Classification by specialty

Gastroenterology

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine an effective and safe regimen as the first-line treatment for H.pylori positive patients less than 40 year-old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Comparison of the eradication rate of the two regimens,PPI+AMPC+CAM vs PPI+AMPC+MNZ for patients less than 40 year-old.

Key secondary outcomes

To evaluate the safety of the two regimens for patients less than 40 year-old.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lansoprazole 30mg+AMPC 750mg+CAM 200mg, twice a day for 7days

Interventions/Control_2

Lansoprazole 30mg+AMPC 750mg+MNZ 250mg, twice a day for 7days

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

13

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male and Female

Key inclusion criteria

Subjects who want to receive a Helicobacter pylori infection test and to take eradication treatment if its result is positive.
Patients who give a written informed consent

Key exclusion criteria

Past history of allergy for the drugs used in this study.
Past history of taking eradication therapy.
Past history of gastrectomy.
Gastric cancer patients, pregnancy or lactation .
Severe renal dysfunction ,Blood disease, Infectious Mononucleosis
Patients who are disqualified for the study by their physicians

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Mototsugu Kato

Organization

Hokkaido University Hospital

Division name

Department of Endoscopy

Zip code

Address

N14,W5,Kita-ku,Sapporo,Hokkaido

TEL

011-716-1161

Email

m-kato@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Katsuhiro Mabe

Organization

Hokkaido University Hospital

Division name

Department of Gastroenterology

Zip code

Address

N14,W5,Kita-ku,Sapporo,Hokkaido

TEL

011-716-1161

Homepage URL

Email

kmabe@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Japan Gast Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.jiac-j.com/article/S1341-321X(18)30078-3/fulltext

Number of participants that the trial has enrolled

Results

We enrolled 1,064 participants.337 participants were diagnosed as having H. pylori infection. 152 patients were randomly assigned to the PAC groups, and 185 were assigned to the PAM group; 15 and 16 patients were excluded from the PAC and PAM groups, respectively . 137 patients were treated with the PAC regimen, and 169 were treated with the PAM regimen.
In the adolescent group, the eradication rates of PAC were 60.5% in the ITT analysis and 63.4% in the PP analysis, and those of PAM were 98.3% in the ITT analysis and 100% in the PP analysis. In the young adult group, the eradication rates of PAC were 67.0% in the ITT analysis and 66.7% in the PP analysis, and those of PAM were 94.6% in the ITT analysis and 95.3% in the PP analysis . The eradication rate of PAM was significantly higher than that of PAC in adolescents and young adults (p < 0.01).
Adverse events
Fifty-eight adverse events were reported among 52 participants (17.0%) (PAC group: 23 [16.8%]; PAM group: 29 [17.2%]). Diarrhoea was the most prevalent adverse event, followed by a skin rash and dysgeusia. No remarkable differences in the occurrence of adverse events were observed between the PAC and PAM groups.

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

2015

Year

03

Month

30

Day

Date of closure to data entry

2015

Year

04

Month

10

Day

Date trial data considered complete

2015

Year

04

Month

30

Day

Date analysis concluded

2015

Year

05

Month

30

Day

Other related information

Registered date

2011

Year

12

Month

25

Day

Last modified on

2018

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007902