Status:
COMPLETED
A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Gastroesophageal Reflux
Heartburn
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
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 defi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00236392
Start Date
October 1 2001
End Date
October 1 2002
Last Update
November 30 2010
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