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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008779
Receipt No. R000010318
Scientific Title An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Rabeprazole
Date of disclosure of the study information 2012/12/01
Last modified on 2014/08/06

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Basic information
Public title An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Rabeprazole
Acronym An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Rabeprazole (CHANGE-R Study)
Scientific Title An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Rabeprazole
Scientific Title:Acronym An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Rabeprazole (CHANGE-R Study)
Region
Japan

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

Objectives
Narrative objectives1 This study is intended to compare the frequency of reflux symptoms in patients with reflux esophagitis who show persistence of symptoms even after continuing treatment with rabeprazole 10 mg once daily for at least 4 weeks, between before and after switching treatment to esomeprazole 20 mg once daily or lansoprazole 30 mg once daily.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in the number of days the patient reported reflux symptoms (heartburn or acid reflux) from the baseline to that during the 1-week period immediately before Week 4.
Key secondary outcomes (1) The number of days the patient reported reflux symptoms during the 1-week period immediately before Week 2.
(2) Resolution rate of reflux symptoms (The proportion of patients who do not report reflux symptoms during the 1-week period immediately before Week 2 or 4).
(3) Remission rate of reflux symptoms (The proportion of patients who do not report reflux symptoms during the 1-week period immediately before Week 2 or 4 or who have mild reflux symptoms [GOS score of 2] for only 1 day during the 1-week period immediately before Week 2 or 4).
(4) Number of day(s) to sustained resolution of reflux symptom (7 constitutive days without reflux symptom in the symptom diary).
(5) Number of day(s) to sustained remission of reflux symptom (7 constitutive days without reflux symptom or with mild reflux symptom on only-1 day, as recorded in the symptom diary).
(6) The change in the GOS upper abdominal symptom score from the baseline to that during the 1-week period immediately before Week 2 or 4.
(7) Reflux symptom score (based on the Symptom Diary) on each day from the following day of study treatment initiation to Week 2.
(8) Factors (e.g., sex, age, BMI, presence or absence of H. pylori infection, lifestyle habits, and comorbidities), which may affect the frequency, resolution, and remission of reflux symptoms.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esomeprazole magnesium hydrate, 20 mg, once daily, 4 weeks (oral capsule)
Interventions/Control_2 Lansoprazole, 30 mg, once daily, 4 weeks (oral capsule or oral disintegrating tablet)
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 aged 20 years or older at the time of providing informed consent.
(2) Patients who were diagnosed with erosive reflux esophagitis (Los Angeles Classification grade A or severer) by endoscopy.
(3) Patients who have been on continuing treatment with rabeprazole 10 mg once daily for at least 4 weeks for reflux esophagitis.
(4) Patients who had moderate or severe reflux symptoms for at least 1 day or mild reflux symptoms for at least 2 days during the 1 week prior to eligibility check.
Specifically, patients whose answers to a Symptom Questionnaire at the time of eligibility check should meet either of the following criteria:
(i) The presence of heartburn or acid reflux for 1 day during the past 1 week and a Global Overall Symptom scale (GOS) score of 4 or higher for either heartburn (Question (ii)) or acid reflux (Question (iii)).
(ii) The presence of heartburn or acid reflux for at least 2 days during the past 1 week and a score of 3 or higher for either heartburn (Question (ii)) or acid reflux (Question (iii)).
(5) Patients who have received complete information about the study and are willing to provide voluntary written consent prior to enrollment in the study.
Key exclusion criteria (1) Patients with a history of hypersensitivity to the study drugs.
(2) Patients with a history of digestive tract resection or vagotomy.
(3) Patients with warning findings such as vomiting, gastrointestinal hemorrhage (including findings such as hematemesis, melena, and anemia) and acute weight loss.
(4) Patients with concurrent peptic ulcer (excluding the scarred stage).
(5) Patients with a past or current history of any of the following diseases:
Zollinger-Ellison syndrome, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), esophageal stenosis, esophageal achalasia, malabsorption, or cerebrovascular disorder such as cerebral hemorrhage and cerebral infarction.
(6) Patients treated for H. pylori eradication within 6 months before the time of eligibility check.
(7) Patients who may have difficulty participating in the study owing to serious complications such as liver, renal, or cardiac diseases.
(8) Patients with a confirmed or possible malignancy.
(9) Women who are pregnant, lactating, or possibly pregnant.
(10) Patients who are on proton pump inhibitors other than lansoprazole.
(11) Patients who need to continue treatment with drugs for which interactions with the study drugs are anticipated.
(12) Patients who are on or need to continue treatment with drugs that are assumed to have an effect on study results.
*However, patients may be enrolled in the study if such drugs are interrupted for 1 week prior to the investigation of the symptoms or are switched to other treatment.
(13) Patients who are determined by the investigator or subinvestigator to be not suitable to be enrolled in the study due to other reasons.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Haruma
Organization Kawasaki Medical School
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 577, Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL 086-462-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Medical School
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 577, Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email

Sponsor
Institute Research Organization for Gastroenterological Disease Treatment
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 12 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 Terminated
Date of protocol fixation
2012 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 25 Day
Last follow-up date
2014 Year 07 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
2012 Year 08 Month 27 Day
Last modified on
2014 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010318

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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