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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003357
Receipt No. R000004033
Scientific Title Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
Date of disclosure of the study information 2010/04/01
Last modified on 2010/03/19

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Basic information
Public title Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
Acronym Study on treatment for patients with refractory reflux esophagitis with proton pump inhibitors.
Scientific Title Study on treatment options for patients with reflux esophagitis who are refractory to proton pump inhibitor administration.
Scientific Title:Acronym Study on treatment for patients with refractory reflux esophagitis with proton pump inhibitors.
Region
Japan

Condition
Condition Reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Therapeutic effect by changing of a proton pump inhibitor to another for patients with refractory reflux esophagitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment effect of omeprazole for patients with reflux esophagitis who are refractory to treatment with ransoprazole.
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Changing of proton pump inhibitor from ransoprazole to omeprazole.
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 who can give a written consent to the entry of the study.

(2) Patients of 20 years old and over without distinction of gender.

(3) Patients who were diagnosed as having reflux esophagitis (Grade M to D).

(4) Patients who are taking ransoprazole 15mg or 30mg per day for more than 2 months.

(5) Patients whose symptoms are more than 8 points by F scale evaluation.
Key exclusion criteria (1) Patients who are under 20 years of age.

(2) Patients who are allergic to the ingredient of the test drugs.

(3) Patients who underwent an operation of intestinal resection or vagotomy.

(4) Patients who have alert symptoms such as nausea, gastrointestinal bleeding and rapid body weight loss.

(5). Patients who had previous medical history of or suffer from the following diseases:Zollinger-Ellison syndrome, inflammatory bowel disease, irritable bowel disease, esophageal stenosis, esophageal achalasia, malabsorption, cerebrovascular disease such as cerebral hemorrhage, cerebral infarction.

(6) Patient who can not participate the study due to the coexistence of the diseases such as severe liver, renal or heart diseases.

(7) Patients who have malignancy or suspected malignancy (Cured patients are eligible).

(8) Patients who are pregnant, in breast-feeding, or may be pregnant.

(9) Patients who need continuous medication with drugs that are contraindication or dangerous to the combination with the test drug.

(10) Patients who take proton pump inhibitors except ransoprazole.

(11) Patients who take drugs that may affect the evaluation of the test drug (Patients who take such drugs without changing the usage or doses during the study period are eligible).

(12) Patients who are not considered to be eligible for the study by the doctor's judgment.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiyoshi Nishio
Organization Department of Gastroenterology and Hepatology
Division name Takii Hospital, Kansai Medical University
Zip code
Address 10-15 Fumizono-cho, Moriguchi, Osaka, Japa
TEL 06-6992-1001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiyoshi Nishio
Organization Department of Gastroenterology and Hepatology
Division name Takii Hospital, Kansai Medical University
Zip code
Address 10-15 Fumizono-cho, Moriguchi, Osaka, Japan
TEL 06-6992-1001
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Kansai 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
2010 Year 04 Month 01 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
2009 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2010 Year 03 Month 19 Day
Last modified on
2010 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004033

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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