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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013708
Receipt No. R000016005
Scientific Title Clinical Characteristics of Patients with Reflux Esophagitis Refractory to Proton Pump Inhibitors and the Effects of Switching to 20 mg Esomeprazole on Reflux Symptoms and Quality of Life
Date of disclosure of the study information 2014/04/14
Last modified on 2020/01/30

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Basic information
Public title Clinical Characteristics of Patients with Reflux Esophagitis Refractory to Proton Pump Inhibitors and the Effects of Switching to 20 mg Esomeprazole on Reflux Symptoms and Quality of Life
Acronym the Effects of Switching to 20 mg Esomeprazole on Reflux Symptoms and Quality of Life
Scientific Title Clinical Characteristics of Patients with Reflux Esophagitis Refractory to Proton Pump Inhibitors and the Effects of Switching to 20 mg Esomeprazole on Reflux Symptoms and Quality of Life
Scientific Title:Acronym the Effects of Switching to 20 mg Esomeprazole on Reflux Symptoms and Quality of Life
Region
Japan

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

Objectives
Narrative objectives1 to examine the effects of switching the PPI on the symptoms and QOL of the patients with refractory reflux esophagitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the proportion of patients who reported an improvement in reflux-related symptoms at 4 weeks after switching to esomeprazole
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 switching to esomeprazole
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 Patients who diagnosed with Grade A or worse reflux esophagitis according to the Los Angeles Classification of endoscopic findings were eligible.
Patients were eligible for the switching study if they had refractory reflux esophagitis, which was defined as scores of>= 4 (moderate or higher) for question 2 (heartburn) or question 3 (acid regurgitation) of the Global Overall Symptom (GOS) questionnaire after treatment with a conventional PPI (omeprazole, lansoprazole, or rabeprazole) for >= 8 weeks.
Key exclusion criteria Patients with any of the following were excluded from the switching study: history of gastric resection or vagotomy; presence of vomiting, gastrointestinal bleeding (including hematemesis, melena, and anemia), or sudden weight loss; history of structural brain disorders, schizophrenia, or a predisposition to schizophrenia; known addiction to alcohol or drugs; presence of serious cardiac, hepatic, renal, or hematopoietic disorders; or a history of hypersensitivity to the ingredients of the study drug.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Fuminao
Middle name
Last name Takeshima
Organization Nagasaki University Hospital
Division name Gastroenterology and Hepatology
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL 81-95-819-7481
Email ftake@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Fuminao
Middle name
Last name Takeshima
Organization Nagasaki University Hospital
Division name Gastroenterology and Hepatology
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL 81-95-819-7481
Homepage URL
Email ftake@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
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 Ethics Committee of the Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
Tel 81-95-819-7217
Email mh-shomu@ml.nagasaki-u.ac.jp

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
2014 Year 04 Month 14 Day

Related information
URL releasing protocol Med Sci Monit. 2015 Dec 31;21:4111-21.
Publication of results Published

Result
URL related to results and publications Med Sci Monit. 2015 Dec 31;21:4111-21.
Number of participants that the trial has enrolled 120
Results
Of 120 patients who completed the survey, 58 (48.3%) had refractory gastroesophageal reflux disease (GERD).After switching to esomeprazole, patients reported significant improvements in heartburn, acid regurgitation, and excessive belching at 2 weeks using a symptom diary, as well as the total score, reflux, abdominal pain, and indigestion, which were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) at 4 weeks. 
Results date posted
2020 Year 01 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
 Overall, 120 patients with GERD treated with conventional PPIs provided informed consent and completed the GOS questionnaire within the study period. Of these, 58 (48.3%) were refractory to PPI therapy based on GOS scores for heartburn or acid regurgitation. Table 1 shows the clinical characteristics of all 120 patients with GERD and 58 patients with refractory GERD.
In the total cohort of 120 patients, about 52% were male, and the mean age and body mass index were 67.1 years and 24.1 kg/m2, respectively. The Los Angeles classification was grade A in 39.2%, grade B in 14.2%, and grade C or worse in 3.3% of patients. The prior PPI was administered at a half dose, standard dose, and double dose/higher in 31.7%, 63.3%, and 5.0% of patients, respectively. The most common PPI was 10 mg rabeprazole (30.8% of patients), followed by 20 mg omeprazole (25.8%), 10 mg omeprazole (17.5%), and 15 mg lansoprazole (14.2%). 
Participant flow
First, we asked patients to complete the GOS to identify patients with refractory GERD.
We next conducted a prospective, nonrandomized, open-label, uncontrolled study in which patients with refractory GERD who required maintenance therapy were switched to oral esomeprazole at a dose of 20 mg once daily for 4 weeks.  
Adverse events
No adverse event.
Outcome measures
About half of Japanese patients with GERD may be refractory to conventional PPIs. Their reflux-related symptoms are often severe and may impair QOL. Switching to esomeprazole could be used to improve their symptoms and QOL. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
2012 Year 01 Month 30 Day
Anticipated trial start date
2012 Year 04 Month 06 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 14 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016005

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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