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

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Rabeprazole

Criteria

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