UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010450 |
|---|---|
| Receipt number | R000012218 |
| Scientific Title | Study of the improvement effect of proton pump inhibitors on symptoms in patients with reflux esophagitis (RE): a randomized double-blind comparative study of esomeprazole 20mg vs. rabeprazole 10mg |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2014/11/10 09:12:29 |
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Basic information
Public title
Study of the improvement effect of proton pump inhibitors on symptoms in patients with reflux esophagitis (RE): a randomized double-blind comparative study of esomeprazole 20mg vs. rabeprazole 10mg
Acronym
Speedy study
Scientific Title
Study of the improvement effect of proton pump inhibitors on symptoms in patients with reflux esophagitis (RE): a randomized double-blind comparative study of esomeprazole 20mg vs. rabeprazole 10mg
Scientific Title:Acronym
Speedy study
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare improvement of day-time and night-time heartburn during 1 week of treatment of esomeprazole 20mg/day vs. rabeprazole 10mg/day in patients with reflux esophagitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of symptom score in day-time and night-time heartburn during 1 week of treatment
Key secondary outcomes
(1) Percentage of patientss who achieve complete relief in day-time and night-time heartburn during 1 week of treatment
(2) Change of symptom score in sleep disorder during 1 week of treatment
(3) Change of symptom score in day-time and night-time heartburn during 1 week of treatment according to severity before treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Esomeprazole 20mg orally once a day in the morning
Interventions/Control_2
Rabeprazole 10mg orally 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 freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.
(2)Patients of either sex who are at least 20 years of age.
(3)Patients diagnosed endoscopically in the past 12 months with Grade A-D (Los Angeles classification) reflux esophagitis
(4)Patients who have moderate or severe degree of day-time and night-time heartburn at least once a week prior to treatment
Key exclusion criteria
(1)Patients with a history of gastrointestinal resection or vagotomy
(2) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), and sudden weight loss
(3) Patients with peptic ulcer (except those in scarring stage)
(4) Patients with a history of, or who currently have, any of the following diseases:
- Zollinger-Ellison syndrome
- Inflammatory Bowel Disease (IBD)
- Irritable Bowel Syndrome (IBS)
- Esophageal stricture
- Esophageal achalasia
- Malabsorption
- Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction
(5) Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, or cardiac disease.
(6) Patients with a confirmed, or suspected, malignant lesion
(7) Women who are pregnant or who may possibly be pregnant, and lactating mothers
(8) Patients under atazanavir sulfate administration
(9) Patients receiving treatment with proton pump inhibitors, H2-receptor antagonists, prokinetic agents, gastric mucosa protective agents, anticholinergics, antidepressants, antianxiety agents, steroids (excluding external preparations), non-steroid anti-inflammatory drugs (NSAIDs), aspirin preparations including low-dose aspirin,anticoagulant drugs and bisphosphonate drugs in the past 2 week prior to treatment.
(10) Other patients whom the investigator considers unsuitable for admission to the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Nagahara |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Nagahara |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Department of Gastroenterology and Hepatology
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
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
北海道大学病院（北海道）、群馬大学医学部附属病院（群馬県）、日本医科大学千葉北総病院（千葉県）、横浜市立大学附属病院（神奈川県）、浜松医科大学医学部附属病院（静岡県）、大阪市立大学医学部附属病院（大阪府）、大阪医科大学附属病院（大阪府）、島根大学医学部附属病院（島根県）、川崎医科大学附属病院（岡山県）、佐賀大学医学部附属病院（佐賀県）/Hokkaido University Hospital(Hokkaido)、Gunma University Hospital(Gunma)、Nippon Medical School,Chiba Hokusou Hospital(Chiba)、Yokohama City University Hospital(Kanagawa)、Hamamatsu University School of Medicine,University Hospital(Shizuoka)、Osaka City University Hospital(Osaka)、Osaka medical college hospital(Osaka)、Shimane University Hospital(Shimane)、Kawasaki medical school hospital(Okayama),Saga Medical School Hospital(Saga)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 22 | 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
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012218
