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

This study has been completed.
Study NCT00165646.   Last updated on July 31, 2007.   Information provided by Eisai Medical Research Inc.

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Descriptive Information Fields
Brief Title  A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-Erosive Gastroesophageal Reflux Disease
Official Title  A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-Erosive Gastroesophageal Reflux Disease
Brief Summary

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study. Primary endpoint is set as complete relief rate of heartburn at the end of evaluation.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Effects of E3810 on heartburn will be evaluated using patients' heartburn diary. The severity of heartburn will be graded as "mild," "moderate," or "severe."
Secondary Outcome Measure 
Condition  Non-Erosive Gastroesophageal Reflux Disease
Intervention  Drug: RABEPRAZOLE SODIUM
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  300
Start Date  September 2004
Completion Date
Eligibility Criteria 

Inclusion Criteria:

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

<For the observation period>

  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.

<For the treatment period>

  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.
Gender Both
Ages 20 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00165646
Organization ID E3810-J081-461
Secondary IDs ††
Study Sponsor  Eisai Inc.
Collaborators †† Eisai Limited
Investigators 
Study Director:     Nobuyuki Sugisaki     Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center    
Information Provided By Eisai Medical Research Inc.
Verification Date July 2007
First Received Date  September 12, 2005
Last Updated Date July 31, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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