UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018776 |
|---|---|
| Receipt number | 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 16:48:13 |
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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
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
t-oshima@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021568
