UMIN-CTR Clinical Trial

Public title

An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Lansoprazole

Acronym

An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Lansoprazole (CHANGE-L Study)

Scientific Title

An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Lansoprazole

Scientific Title:Acronym

An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Lansoprazole (CHANGE-L Study)

Region

Japan

Condition

reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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 lansoprazole 15 or 30 mg once daily for at least 4 weeks, between before and after switching treatment to esomeprazole 20 mg once daily or rabeprazole 10 mg once daily.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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.

Study type

Interventional

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

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

Rabeprazole sodium (oral tablet), 10 mg, once daily, 4 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 lansoprazole 15 or 30 mg once daily for at least 4 weeks for reflux esophagitis.
However, patients who had a change in the dosage of lansoprazole within 4 weeks of Visit 1 will be excluded.
(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

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

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

Institute

Research Organization for Gastroenterological Disease Treatment

Institute

Department

Personal name

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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=R000010321