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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018776
Receipt No. R000021568
Scientific Title Speed of the relief of GERD symptoms by acid suppressants in reflux esophagitis
Date of disclosure of the study information 2015/08/23
Last modified on 2018/12/30

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Basic information
Public title Speed of the relief of GERD symptoms by acid suppressants in reflux esophagitis
Acronym The relief of GERD symptom in reflux esophagitis
Scientific Title Speed of the relief of GERD symptoms by acid suppressants in reflux esophagitis
Scientific Title:Acronym The relief of GERD symptom in reflux esophagitis
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy of vonoprazan (20 mg/day) vs. lansoprazole (30 mg/day) for 2 week treatment in patients with reflux esophagitis by assessing the time (days) to be GERD symptom relief
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time (days) to GERD symptom relief
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vonoprazan (Takecab) 20 mg once a day in the morning
Interventions/Control_2 Lansoprazole (Takepron) 30 mg once a day in the morning
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 have given written consent to participate in the study.
2. Patients who are at least 20 years of age.
3. Patients who undergo upper gastrointestinal endoscopy within 2 months from the visit and are found to have reflux esophagitis (Los Angeles classification, Grade A-D)
Key exclusion criteria 1. Patients with conditions that are likely to cause upper abdominal symptoms such as malignant tumors, peptic ulcers and systemic diseases (neurological diseases including Parkinson's disease, metabolic diseases including diabetes, etc).
2. Patients with known causes of upper abdominal symptoms including excessive drinking, overeating, taking NSAIDs, and sever stress.
3. Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6665
Email miwa-hgi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadayuki Oshima
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6662
Homepage URL
Email t-oshima@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s) None

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
2015 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/apt.15062
Number of participants that the trial has enrolled
Results
Complete sustained heartburn relief was achieved sooner with vonoprazan than with lansoprazole during the first week of therapy
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
2015 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 24 Day
Last follow-up date
2017 Year 09 Month 20 Day
Date of closure to data entry
2017 Year 11 Month 12 Day
Date trial data considered complete
2017 Year 11 Month 12 Day
Date analysis concluded
2018 Year 10 Month 26 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 23 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021568

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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