UMIN-CTR Clinical Trial

Public title

The effect of esomeprazole on acid suppression in Japanese-evaluation with the endoscopic gastrin test, EGT-

Acronym

The rate of acid suppression of administration of esomeprazole.

Scientific Title

The effect of esomeprazole on acid suppression in Japanese-evaluation with the endoscopic gastrin test, EGT-

Scientific Title:Acronym

The rate of acid suppression of administration of esomeprazole.

Region

Japan

Condition

Gastroesophageal reflux disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To compare the rate of acid suppression of esomeprazole administration in various dosage and timing.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare the rate of acid suppression at the steady state(at 14:00 on day7) among each group.

Key secondary outcomes

To compare the rate of acid suppression of esomeprazole at 8:00 on day15* among each group.
*at 8:00 on day15: Twenty-four hours after last administration for once daily and 10 hours after last administration for twice daily
To evaluate the background factors that affect the acid suppression, such as H.pylori infecton, CYP2C19 polymophism in three groups.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00.-wash out 2-4week esomeprazole10mg before meal once a day at 08:00

Interventions/Control_2

esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00

Interventions/Control_3

esomeprazole20mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week esomeprazole10mg bofore meal once a day at 08:00

Interventions/Control_4

esomeprazole20mg before meal once a day at 08:00-wash out 2-4week- esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00

Interventions/Control_5

esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00

Interventions/Control_6

esomeprazole10mg before meal once a day at 08:00-wah out 2-4wek-esomeprazole20mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male

Key inclusion criteria

1. healthy volunteer
1. Subjects provide written voluntary consent to participate in the study after sufficient written and oral explanation.

Key exclusion criteria

1. Subjects with past history of drug allergy
2. Subjects with hepatic, renal, or cardiac disorder
3. Subjects with a history of gastrectomy and/or vagotomy
4. Subjects who are on any treatment
5. Subjects who need to receive any drugs other thanthe study drug during the study.
6. Others as judged inappropriate by the investigator(s)

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Tomoyuki Koike

Organization

Tohoku University Graduate Schooi of Medicine

Division name

Division of Gastroenterology

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Snedai

TEL

Email

Name of contact person

1st name
Middle name
Last name	Tomoyuki Koike

Organization

Tohoku University Graduate Schooi of Medicine

Division name

Division of Gastroenterology

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Snedai

TEL

Homepage URL

Email

Institute

Division of Gastroenterology, Tohoku University Graduate Schooi of Medicine

Institute

Department

Personal name

Organization

Non-profit Organization for Promotion of Gastrointestinal Disease Treatment Research

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

東北大学病院　消化器内科

Date of disclosure of the study information

2012

Year

10

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

20

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

09

Day

Last modified on

2014

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010639