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

• ClinicalTrials.gov Identifier: NCT00165646
• Recruitment Status: Completed
• First Posted: September 14, 2005
• Results First Posted: June 17, 2011
• Last Update Posted: July 18, 2011
• Sponsor: Eisai Co., Ltd.
• Information provided by: Eisai Inc.

Study Description

Brief Summary:

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

Condition or disease	Intervention/treatment	Phase
Non-erosive Gastroesophageal Reflux Disease	Drug: E3810; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
• Study Start Date: September 2004
• Actual Primary Completion Date: October 2005
• Actual Study Completion Date: October 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: E3810; E3810 5mg: once daily orally for 4 weeks
Experimental: 2	Drug: E3810; E3810 10mg: once daily orally for 4 weeks
Placebo Comparator: 3	Drug: Placebo; Placebo: once daily orally for 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Complete Relief of Heartburn at Final Evaluation [ Time Frame: 4 weeks ]
   "Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Aichi-Gun, Aichi-Prefecture, Japan, 480-1103

Nagoya, Aichi-Prefecture, Japan, 466-0065

Nagoya, Aichi-Prefecture, Japan, 467-0001

Chikushino, Fukuoka-Prefecture, Japan, 818-0024

Chikushino, Fukuoka-Prefecture, Japan, 818-0067

Fukuoka, Fukuoka-Prefecture, Japan, 813-0003

Kita-kyushu, Fukuoka-Prefecture, Japan, 807-1262

Maebashi, Gunma-Prefecture, Japan, 371-0034

Hiroshima, Hiroshima-Prefecture, Japan, 730-0052

Hiroshima, Hiroshima-Prefecture, Japan, 734-0037

Sapporo, Hokkaido-Prefecture, Japan, 003-0021

Sapporo, Hokkaido-Prefecture, Japan, 060-0061

Sapporo, Hokkaido-Prefecture, Japan, 060-0814

Kochi, Kochi-Prefecture, Japan, 780-0901

Kyoto, Kyoto-Prefecture, Japan, 602-0000

Kyoto, Kyoto-Prefecture, Japan, 606-8397

Sandai, Miyagi-Prefecture, Japan, 980-0872

Sendai, Miyagi-Prefecture, Japan, 984-0075

Moriguchi, Osaka-Prefecture, Japan, 570-0021

Osaka, Osaka-Prefecture, Japan, 530-0012

Osaka, Osaka-Prefecture, Japan, 536-0002

Osaka, Osaka-Prefecture, Japan, 545-0051

Saga, Saga-Prefecture, Japan, 849-0937

Kawaguchi, Saitama-Prefecture, Japan, 332-0021

Izumo, Shimane-Prefecture, Japan, 693-0021

Matsue, Shimane-Prefecture, Japan, 690-0886

Hamamatsu, Shizuoka-Prefecture, Japan, 431-3125

Shinagawa-ku, Tokyo, Japan, 140-0011

Shinjuku-ku, Tokyo, Japan, 162-0052

Sanyoonoda, Yamaguchi-Prefecture, Japan, 756-0076

Sanyoonoda, Yamaguchi-Prefecture, Japan, 757-0002

Ube, Yamaguchi-Prefecture, Japan, 755-0004

Ube, Yamaguchi-Prefecture, Japan, 755-0046

Ube, Yamaguchi-Prefecture, Japan, 755-0067

Ube, Yamaguchi-Prefecture, Japan, 755-0077

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators

• Study Director: Nobuyuki Sugisaki; Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

More Information

• Responsible Party: Nobuyuki Sugisaki, Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00165646
• Other Study ID Numbers: E3810-J081-461
• First Posted: September 14, 2005
• Results First Posted: June 17, 2011
• Last Update Posted: July 18, 2011
• Last Verified: August 2010

Keywords provided by Eisai Inc.:

non-erosive gastroesophageal reflux disease; NERD; proton pump inhibitor; rabeprazole

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophagitis, Peptic; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Rabeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action