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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005943
Receipt No. R000007023
Scientific Title The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Date of disclosure of the study information 2011/07/07
Last modified on 2011/07/06

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Basic information
Public title The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Acronym The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Scientific Title The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Scientific Title:Acronym The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Region
Japan

Condition
Condition Mild gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of GERD symptoms using Frequency Scale for the Symptoms of GERD (FSSG)
Key secondary outcomes Record of symptoms
Frequency of heartburn during day and night
Evaluation of QOL using Face Scale

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lafutidine
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with Grade N, M, A or B (Los Angeles classification) mild GERD
2) Patients with heartburn symptoms once or more a week
3) More than 20 years old Patients who agree to participate in the study on a written informed consent form
Key exclusion criteria 1) Patients with hypersensitivity for Lafutidine
2) Patients with serious liver abnormality
3) Patients who took gastric acid inhibitors such as proton pump inhibitor and H2 blocker within 1 week
4) Patients who taking medicine which interfere with the study
5) Patients with depression symptoms
6) Patients considered inappropriate by the study investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikitaka Iguchi
Organization Wakayama Medical University
Division name Internal Medicine (Second Department)
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Wakayama Medical University
Division name Internal Medicine (Second Department)
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Homepage URL
Email

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 07 Month 07 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 Open public recruiting
Date of protocol fixation
2011 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 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 07 Month 06 Day
Last modified on
2011 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007023

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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