UMIN-CTR Clinical Trial

Public title

Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms -randomized, parallel group, open-label study-

Acronym

Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms

Scientific Title

Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms -randomized, parallel group, open-label study-

Scientific Title:Acronym

Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms

Region

Japan

Condition

Patients with upper gastrointestinal symptoms

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of the study is to compare the symptomatic efficacy of omeprazole with that of famotidine, mosapride and teprenone in H. pylori-negative patients with upper gastrointestinal symptoms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoint is to compare the proportion of patients with sufficient overall symptom relief of their upper gastrointestinal symptoms after 4 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone.

Key secondary outcomes

The secondary endpoints are as follows:
(1) To compare the proportion of patients with complete overall symptom relief of their upper gastrointestinal symptoms after 4 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone.
(2) To compare the proportion of patients with sufficient overall symptom relief after 2 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone.
(3) To compare the proportion of patients with sufficient overall symptom relief after 4 weeks of treatment for each symptom, such as heartburn with omeprazole, famotidine, mosapride or teprenone.
(4) To examine demographic and clinical characteristics and their association with sufficient overall symptom relief on multivariate logistic regression analysis.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Omeprazole 10mg orally once daily

Interventions/Control_2

Famotidine 10mg twice daily

Interventions/Control_3

Mosapride 5mg three times daily

Interventions/Control_4

Teprenone 50mg three times daily

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

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Patients who have chronic or recurrent episodes of at least one of specific upper GI symptoms, such as heartburn, regurgitation, epigastric pain, postprandial fullness, nausea/vomiting, belching, early satiety and/or bloating, and endoscopically uninvestigated in the past three months.
(2) Patients who have one or more of the symptoms being of at least moderate severity (Global Overall Symptom score [GOS] >= 4) in the previous week.
(3) Male or female aged 20 to 65 years.
(4) Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.

Key exclusion criteria

(1) Patients who have alarm symptoms, such as vomiting, gastrointestinal bleeding or acute weight loss requiring endoscopy.
(2) Patients who are judged by the investigator to require a prompt endoscopy.
(3) Patients who have a confirmed or suspected malignant lesion.
(4) Patients who have prior gastrointestinal resection or vagotomy.
(5) Patients with irritable bowel syndrome.
(6) PPIs, H2-receptor antagonists, prokinetic agents, gastric mucosal protective agents, anticholinergics, antidepressants, anxiolytics, steroids (other than topical steroids), non-steroidal anti-inflammatory drugs, aspirin or bisphosphonates were discontinued at least 1 week before study entry and were not allowed during the study period.
(7) Patients who are judged to be ineligible for study entry due to serious hepatic, renal, or cardiac disease.
(8) Patients who might possibly be pregnant or were lactating.
(9) Patients who are judged to be ineligible for study entry by the investigator.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Ken Haruma

Organization

Kawasaki Medical School

Division name

Department of Internal Medicine, Division of Gastroenterology

Zip code

Address

577 Matsushima, Kurashiki, Okayama, 701-0192, Japan

TEL

086-462-1111

Email

Name of contact person

1st name
Middle name
Last name	Yasunori Kato

Organization

Japan Dyspepsia Society Support Center

Division name

Mebix, Inc, Clinical Research

Zip code

Address

2-5-5 Shiba Daimon, Minato-ku, Tokyo

TEL

03-5472-7138

Homepage URL

Email

j-dyspepsia@mebix.co.jp

Institute

Japan Dyspepsia Society

Institute

Department

Personal name

Organization

The Waksman Foundation of Japan INC.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

04

Month

08

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

2006

Year

12

Month

06

Day

Date of IRB

Anticipated trial start date

2007

Year

02

Month

01

Day

Last follow-up date

2008

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

07

Day

Last modified on

2011

Year

04

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006410