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

Eisai Inc.0 sites26 target enrollmentMay 2005

ConditionsNon-erosive Gastroesophageal Reflux Disease

InterventionsRABEPRAZOLE SODIUM

DrugsRABEPRAZOLE SODIUM

Overview

Phase: Phase 3
Intervention: RABEPRAZOLE SODIUM
Conditions: Non-erosive Gastroesophageal Reflux Disease
Sponsor: Eisai Inc.
Enrollment: 26
Primary Endpoint: 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).
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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)).

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

October 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

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\>
•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.
•Patients who meet both 1) and 2) below;
•The symptom is a burning sensation arising from the stomach or the lower chest.
•The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
•Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
•Patients who are 20 years old or older at the time of obtaining consent.
•Patients who are informed of the objective and details of this study and give written consent for study entry.
•\<For the treatment period\>

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from the study.
•Patients who cannot keep adequate entries of a heartburn diary by themselves.
•Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
•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).
•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.
•Patients with open gastric or duodenal ulcer.
•Patients with acute gastritis.
•Patients with a history of any surgical intervention that affect peptic secretion (e.g., upper gastrointestinal tract resection and/or vagotomy).
•Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
•Patients with scleroderma.

Arms & Interventions

1

Intervention: RABEPRAZOLE SODIUM

2

Intervention: RABEPRAZOLE SODIUM

Outcomes

Primary Outcomes

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).

Time Frame: Baseline and 4 weeks

Mean and standard deviation of percent time pH\<4.0 on 24 hour esophageal pH monitoring.