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

Last updated: November 29, 2010
Sponsor: Janssen Pharmaceutica N.V., Belgium
Overall Status: Completed

Phase

3

Condition

Heartburn

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT00236392
CR003121
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Minimum of 12 months history of heartburn as the predominant symptom with at least 2symptomatic 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 acutetreatment

Exclusion

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 requirestreatment

  • no history of erosive reflux causing inflammation of the esophagus

  • no stricture of the esophagus, stomach, or any condition that causes difficulty inswallowing

  • no history of non-erosive reflux disease (NERD) that is or was refractory to anadequate treatment course (1 month) with proton pump inhibitors

  • no females who are pregnant or those lacking adequate contraception

Study Design

Total Participants: 422
Study Start date:
October 01, 2001
Estimated Completion Date:
October 31, 2002

Study 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.