A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00165646
• Date of registration: 12/09/2005
• Primary sponsor: Eisai Co., Ltd.
• Public title: A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
• Scientific title: A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
• Date of first enrolment: September 2004
• Target sample size: 288
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00165646
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Nobuyuki Sugisaki
• Affiliation: Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

Key inclusion & exclusion criteria

Inclusion Criteria:

The patients to be included will be outpatients who meet all of the following criteria. No
specific gender is asked.



1. Patients who have "heartburn" 2 days a week or more for consecutive weeks during 3
weeks prior to pre-observation screening. If a day of screening and a day of starting
observation (date of registration) are different, heartburn must continuously be
present during the in-between period.

2. Patients who meet both 1) and 2) below; 1) The symptom is a burning sensation arising
from the stomach or the lower chest.

2) The symptom tends to appear frequently or is aggravated after eating, when bending a
body forward, and/or when pressing on the abdomen.

(3) Patients categorized in "grade M" (discoloring type: minimal change) according to the
Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.

(4) Patients who are 20 years old or older at the time of obtaining consent. (5) Patients
who are informed of the objective and details of the study and give written consent for
study entry.



1. Patients who have "heartburn" on 2 days a week or more in 7 days immediately before
the treatment period (during the observation period).

2. Patients with "heartburn diary" that is completely filled out for 7 days until the
treatment period (during the observation period). If the observation period is 8 days
or longer, those with heartburn diary of which entries are fulfilled 80% or more
during the observation period.

3. Patients with 80% or better drug compliance for antacids during the observation
period.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Patients who cannot keep adequate entries of heartburn diary by themselves.

2. Patients who strongly complain "feeling of heavy stomach" and/or "abdominal
bloating."

3. Patients who have a complication or history of psychiatric or psychosomatic disease
(e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those
who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic
treatment).

4. Patients who have undergone Helicobacter pylori eradication therapy, and less than 6
months have elapsed from the end of H. pylori eradication therapy to the beginning of
the observation period. : The same day 6 months earlier, and the day at the end of 6
months earlier if it is at the end of month.

5. Patients with open gastric or duodenal ulcer.

6. Patients with acute gastritis.

7. Patients with a history of any surgical intervention that affect peptic secretion
(e.g., upper gastrointestinal tract resection and/or vagotomy).

8. Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.

9. Patients with scleroderma.

10. Patients with a history or complication of angina pectoris.

11. Patients who work at night (working for a night-shift).

12. Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to
pre-observation screening

13. Patients who need NSAIDs (except topical preparations), steroids (except topical
preparations), and/or aspirin treatment every day

14. Patients receiving dialysis therapy

15. Patients with a serious complication such as cardiovascular disease (e.g., myocardial
infarction), hematological disorder (e.g., aplastic anemia), renal disease (e.g.,
acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant
tumor.

16. Patients with known hypersensitivity to antacids or PPIs.

17. Patients who are pregnant or those with childbearing potential, or those who wish to
become pregnant or are lactating during the study period.

18. Patients receiving another investigational drug or those who received another
investigational drug within 6 months prior to pre-observation screening :
Registration is allowed on the same day of 6 months earlier, and the day at the end
of 6 months earlier if it is at the end of month.

19. Patients who are judged to be ineligible for the study entry by the investigator or
subinvestigator.



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-erosive Gastroesophageal Reflux Disease

Intervention(s)

Drug: E3810

Drug: Placebo

Primary Outcome(s)

Percentage of Participants With Complete Relief of Heartburn at Final Evaluation [Time Frame: 4 weeks]

Secondary ID(s)

E3810-J081-461

Source(s) of Monetary Support

Please refer to primary and secondary sponsors