UMIN-CTR Clinical Trial

Public title

A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
-Investigation of response to proton pump inhibitor (PPI) therapy and factors involved-

Acronym

A prospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)

Scientific Title

A fact-finding study on the treatment of gastroesophageal reflux disease (GERD)
-Investigation of response to proton pump inhibitor (PPI) therapy and factors involved-

Scientific Title:Acronym

A prospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)

Region

Japan

Condition

Gastroesophageal reflux disease (GERD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the response of gastroesophageal reflux disease (GERD) symptoms to proton pump inhibitor (PPI) therapy based on a patient questionnaire, and examine the extent of involvement of background factors that can affect treatment response

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Extent of involvement of individual background factors in the treatment response based on symptoms as measured using a patient questionnaire (GERD-TEST)

Key secondary outcomes

(1) Differences in background factors between ERD patients and NERD patients
(2) Responses of ERD and NERD to PPI therapy
(3) Association between psychological bias and treatment response
(4) Association between GERD-TEST and SF-8
(5) Association among individual parameters observed or measured

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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) Patients who have provided written consent of their own free will to participate in the study after receiving sufficient written or verbal information about the study
2) Patients of both sexes aged 20 years or above.
3) Patients with heartburn or acid regurgitation of moderate or higher severity occurring at least once a week, or that of mild severity occurring at least twice a week, during the two weeks prior to the start of the study

Key exclusion criteria

1) Patients with a history of gastrointestinal resection or vagotomy
2) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss
3) Patients with concurrent peptic ulcer (not in the scarring stage)
4) Patients with a prior or current history of any of the following diseases:
- Zollinger-Ellison syndrome
- Inflammatory bowel disease (IBD)
- Irritable bowel syndrome (IBS)
- Esophageal stricture
- Eosinophilic reflux esophagitis
- Esophageal achalasia
- Malabsorption
- Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction
5) Patients complicated by serious hepatic, renal, cardiac, or other diseases for which the participation in the study would be difficult
6) Patients with a confirmed or suspected malignant lesion
7) Patients who are pregnant, breastfeeding, or may be pregnant
8) Patients considered to require continued use of any drugs that could interact with the study drugs (i.e., atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, antacids containing aluminium hydroxide gel and magnesium hydroxide, and clopidogrel)
9) Patients with a history of hypersensitivity to any components of proton pump inhibitor products
10) Patients who received a proton pump inhibitor or an H2-receptor antagonist within one week prior to enrollment in this study
11) Patients who underwent H. pylori eradication within six months prior to the start of the study
12) Patients with any concurrent disease interfering with normal living (e.g., psychiatric disease, poorly controlled metabolic disease, neurological disease, collagen disease)
13) Other patients judged by the physician to be inappropriate for this study

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Ken Haruma

Organization

Kawasaki Medical School

Division name

Gastroenterology, Ultrasonology, and Translational Medicine & Nutrition

Zip code

Address

577 Matsushima, Kurashiki, Okayama 701-0192, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

GERD Society

Division name

Secretariat

Zip code

Address

TEL

Homepage URL

Email

gerd@mcp.co.jp

Institute

GERD Society

Institute

Department

Personal name

Organization

None

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

2011

Year

10

Month

27

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

2011

Year

02

Month

28

Day

Date of IRB

Anticipated trial start date

2011

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A prospective nonrandomized multicenter observational study.
Patients with heartburn or acid regurgitation of moderate or higher severity occurring at least once a week, or that of mild severity occurring at least twice a week, during the two weeks prior to the start of the study are asked to answer the questionnaire before and after PPI medication.
1) Drugs for PPI therapy
Omeprazole tablet 20mg
Lansoprazole Capsule or OD tablet 30mg
Rabeprazole tablet 10mg or 20mg
2) Administration
Once daily oral administration
3) Administration period
4 weeks
4) Questionnaire
GERD-TEST, SF-8, HADS

Registered date

2011

Year

10

Month

26

Day

Last modified on

2014

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007822