A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).

Study Overview

• Status: Completed
• Conditions: Non-erosive Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: RABEPRAZOLE SODIUM; Drug: RABEPRAZOLE SODIUM

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi-Prefecture
    • Nagoya, Aichi-Prefecture, Japan, 467-0001
  • Fukuoka-Prefecture
    • Fukuoka, Fukuoka-Prefecture, Japan, 810-0001
    • Fukuoka, Fukuoka-Prefecture, Japan, 811-0213
    • Yukuhashi, Fukuoka-Prefecture, Japan, 824-0026
  • Hiroshima-Prefecture
    • Hiroshima, Hiroshima-Prefecture, Japan, 734-0037
  • Osaka-Prefecture
    • Osaka, Osaka-Prefecture, Japan, 530-0012
    • Osaka, Osaka-Prefecture, Japan, 545-0051
  • Saga-Prefecture
    • Saga, Saga-Prefecture, Japan, 849-0937
  • Shiga-Prefecture
    • Otsu, Shiga-Prefecture, Japan, 520-2121
  • Shimane-Prefecture
    • Izumo, Shimane-Prefecture, Japan, 693-0021
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-0022
    • Shinjuku-ku, Tokyo, Japan, 162-0052
  • Yamaguchi-Prefecture
    • Ube, Yamaguchi-Prefecture, Japan, 755-0046

Participation Criteria

Eligibility Criteria

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

Description

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 during consecutive 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 this study and give written consent for study entry.

<For the treatment period>

1. Patients who have "heartburn" 2 days a week or more during 7 days until the treatment period (during the observation period).
2. Patients with "heartburn diary" that is completely filled out during 7 days until the treatment period (during the observation period). If the observation period is 8 days or longer, those with a 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.
4. Patients whose percentage of time showing pH<4.0 (% time pH<4.0) is not 0%* during the 24-hour esophageal pH monitoring at the end of observation period (at the beginning of treatment period). *If parameters calculated from analytical program show 0.0% after round-off, this patient cannot be entered into the treatment 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 a 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 non steroidal anti-inflammatory drugs (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 (myocardial infarction, etc.), 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RABEPRAZOLE SODIUM; rabeprazole sodium 5 mg: once daily orally for 4 weeks; Drug: RABEPRAZOLE SODIUM; rabeprazole sodium 10 mg: once daily orally for 4 weeks
Experimental: 2	Drug: RABEPRAZOLE SODIUM; rabeprazole sodium 5 mg: once daily orally for 4 weeks; Drug: RABEPRAZOLE SODIUM; rabeprazole sodium 10 mg: once daily orally for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).	Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Eisai Limited
• Investigators: Study Director: Nobuyuki Sugisaki, Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: proton pump inhibitor; NERD; rabeprazole; non-erosive gastroesophageal reflux disease; 24-hour esophageal pH monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-J081-462