UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008779
Receipt number 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 11:01:50

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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 or person

Institute

Research Organization for Gastroenterological Disease Treatment

Institute

Department

Personal name



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

Value
https://center6.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