A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)

Sponsor

Janssen Pharmaceutica N.V., Belgium (Industry)

Overall Status

Completed

CT.gov ID

NCT00236392

Collaborator

(none)

422

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of long-term, "on-demand" maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Heartburn	Drug: rabeprazole	Phase 3

Detailed Description

More than half of patients with typical gastroesophageal reflux symptoms such as heartburn are considered to have non-erosive reflux disease (NERD), which is characterized by a lack of clinically defined damage to the esophagus. One approach to maintain control of these symptoms is to have medication available "on-demand." This is a double-blind, placebo-controlled study of the effectiveness of "on-demand" rabeprazole in the long-term maintenance of heartburn control in NERD patients, for whom heartburn was resolved with short-term, daily rabeprazole therapy. The study has two phases: an acute phase (4 weeks) during which patients receive rabeprazole medication daily, and an "on-demand" phase (6 months) during which patients take medication (rabeprazole or placebo) as needed. Only patients who have complete resolution of heartburn at the end of the acute phase are eligible to continue in the "on-demand" phase. Efficacy assessments include the proportion of patients discontinuing treatment in the "on-demand" phase because of insufficient heartburn control, and the severity of heartburn and patient satisfaction determined at the beginning and end of "on-demand" phase. Safety assessments include incidence of adverse events throughout the study, physical examination at study initiation, and vital signs at the beginning and the end of the study. The study hypothesis is that "on-demand" therapy with rabeprazole is superior to placebo in maintaining heartburn control and is well tolerated by the patients with NERD. Rabeprazole tablet (10 milligrams[mg]) once daily in the morning for 4 weeks. Rabeprazole tablets (10mg) once daily on an "on-demand" basis for the following 6 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

422 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Double-Blind Placebo-Controlled Randomized Withdrawal Trial Assessing the Efficacy and Tolerability of "On-Demand" Maintenance Therapy With 10mg o.d. Rabeprazole for 6 Months in Non-Erosive Reflux Disease Patients With Complete Symptom Relief After 4 Week Open Acute Phase

Study Start Date :

Oct 1, 2001

Actual Study Completion Date :

Oct 1, 2002

Outcome Measures

Primary Outcome Measures

Proportion of patients discontinuing treatment in "on-demand" phase (6 months) because of insufficient heartburn control. []

Secondary Outcome Measures

Severity and control of heartburn, overall quality of life (Psychological General Well-Being Index), antacid consumption, and patient satisfaction at the beginning and end of the "on-demand" phase. Incidence of adverse events throughout study []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Minimum of 12 months history of heartburn as the predominant symptom with at least 2 symptomatic episodes
Negative endoscopy (no erosive lesions according to the Modified Savary-Miller scale) within 7 days prior to acute treatment
at least 3 days with moderate to very severe heartburn within one week prior to acute treatment

Exclusion Criteria:

No known gastro-duodenal ulcer
no infections, inflammations, or obstruction of the small or large intestine
no history of gastrointestinal cancer, or prior surgery of the stomach or intestine
no stomach or abdominal pain or discomfort as the predominant symptom or that requires treatment
no history of erosive reflux causing inflammation of the esophagus
no stricture of the esophagus, stomach, or any condition that causes difficulty in swallowing
no history of non-erosive reflux disease (NERD) that is or was refractory to an adequate treatment course (1 month) with proton pump inhibitors
no females who are pregnant or those lacking adequate contraception