UMIN-CTR Clinical Trial

Public title

Evaluation of efficacy in improvement of reflux esophagitis by esomeprazole to the patient treated with conventional PPI.

Acronym

Evaluation of efficacy in improvement of reflux esophagitis by esomeprazole to the patient treated with conventional PPI.

Scientific Title

Evaluation of efficacy in improvement of reflux esophagitis by esomeprazole to the patient treated with conventional PPI.

Scientific Title:Acronym

Evaluation of efficacy in improvement of reflux esophagitis by esomeprazole to the patient treated with conventional PPI.

Region

Japan

Condition

reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of efficacy in improvement of reflux esophagitis by new proton pump inhibitor to the patient treated with conventional PPI.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

F scale

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Esomeprazole

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient who has diagnosis of reflux esophagitis by endoscopic examination.
2)The patient treated with PPI more than four weeks.
3)Above 20 years old.
4)Informed consent.

Key exclusion criteria

The exclusion criteria.
1)The patient who has a history of allergy to the study drug.
2)Patient who is using atazanavir sulfate.
3)The patient with gastrointestinal diseases such as esophageal stenosis, an irritable bowel syndrome, an inflammatory bowel disease, primary esophagus motor deficit, systemic sclerosis, Zollinger-Ellison syndrome, the malabsorption syndrome and so on.
4)The patient with a gastric ulcer, and/or a duodenal ulcer endoscopically.
5)The patient with severe liver, kidney and heart disease.
6)The patient with a history of the digestive surgical operation or vagotomy.
7)Pregnant or lactation woman.
8)The patient who needs the treatment with the following drugs during the study.
Exercise function improvement medicine, gastric mucosa defense factor reinforcement medicine, cholinolytic, antacid, antidepressant, an antianxiety drug, a NSAIDs, low-dose aspirin, bisphosphonate. But the patient uses it before the consent acquisition, and without during changing dosage, a dose during a study time when patient can use it, suppose that combined use is possible.
9)The patient who has to use drug having study drug and interaction.
10)Diazepam, phenytoin, cilostazol, warfarin, a tacrolimus hydrate, digoxin, metildigoxin, itraconazole, a tyrosine kinase inhibior (gefitinib, nilotinib), voriconazole, nelfinavir mesilate, saquinavir mesilate, St. John's wort component food.
11)The patient who was considered ineligible by the investigators.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Tomiyasu Arisawa

Organization

Kanazawa Medical University

Division name

Department of Gastroenterology

Zip code

Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

TEL

076-286-2211

Email

tarisawa@kanazawa-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomiyasu Arisawa

Organization

Kanazawa Medical University

Division name

Department of Gastroenterology

Zip code

Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

TEL

076-286-2211

Homepage URL

Email

tarisawa@kanazawa-med.ac.jp

Institute

Kanazawa Medical University

Institute

Department

Personal name

Organization

Kanazawa Medical University

Organization

Division

Category of Funding Organization

Self funding

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

2012

Year

06

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

01

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

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

06

Month

15

Day

Last modified on

2015

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009627