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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005399
Receipt No. R000006410
Scientific Title Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms -randomized, parallel group, open-label study-
Date of disclosure of the study information 2011/04/08
Last modified on 2011/04/07

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Basic information
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
Condition Patients with upper gastrointestinal symptoms
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Japan Dyspepsia Society
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2011 Year 04 Month 07 Day
Last modified on
2011 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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