UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006162 |
|---|---|
| Receipt number | R000007280 |
| Scientific Title | Clinical effect of lafutidine (Protecadin) on the mild case of Reflux Disease (health care economic comparison of which it contrasts Lansoprazole) |
| Date of disclosure of the study information | 2011/08/22 |
| Last modified on | 2011/08/12 18:05:40 |
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Basic information
Public title
Clinical effect of lafutidine (Protecadin) on the mild case of Reflux Disease
(health care economic comparison of which it contrasts Lansoprazole)
Acronym
Clinical effect of lafutidine (Protecadin) on the mild case of Reflux Disease
(health care economic comparison of which it contrasts Lansoprazole)
Scientific Title
Clinical effect of lafutidine (Protecadin) on the mild case of Reflux Disease
(health care economic comparison of which it contrasts Lansoprazole)
Scientific Title:Acronym
Clinical effect of lafutidine (Protecadin) on the mild case of Reflux Disease
(health care economic comparison of which it contrasts Lansoprazole)
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to clarify clinical effect of lafutidine (Protecadin) on the patients of low- grade reflux esophagitis
(health care economic comparison of which it contrasts Lansoprazole)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the change of degree of symptoms of patients after eight weeks of PPI or H2RA administering
Key secondary outcomes
evaluation of the change of symptoms of patients until 24 weeks after administration PPI or H2RA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lafutidine 20mg after breakfast and supper(or at bedtime)(eight weeks)
Interventions/Control_2
Lansoprazole 30mg after breakfast(eight weeks)
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)Patient diagnosed as LA classification Grade A by endoscopy within seven days before start of the study
2)Patient whose either score of question 2 or question 3 on GSRS interview sheet is three or more when study is registered
Key exclusion criteria
1)Patient with gastroduodenal ulcer (ulcer scar is assumed to be acceptable)
and cancer of upper gastroitestinal tract
2)Patient with barett's epithelium extends it to part by ..distal portion of esophagus.. exceed 3cm
3)Patient with past history of operation of upper gastrointestinal tract
4)Patient who had taken PPI and H2RA within 2weeks before endscopy
5)Severe disease in heart, liver and kidney
6)Drug allergy for laftidine, lansoprazole and other drugs
7)expectant mother, mother with breast-feeding
8)other not applicable person recognized by a doctor
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
88-1, Enya, Izumo, Shimane 693-8501
TEL
0853-20-2190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Furuta |
Organization
Shimane University Faculty of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
88-1, Enya, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
Sponsor or person
Institute
PROMISE study Society
Institute
Department
Personal name
Funding Source
Organization
PROMISE study Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
PROMISE study Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 08 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2011 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007280
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
