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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2002-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Heartburn

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gastroesophageal reflux Heartburn Rabeprazole Anti-ulcer agents GERD Proton pump inhibitor GORD Non-Erosive Reflux Disease NERD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rabeprazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

References

Explore related publications, articles, or registry entries linked to this study.

Bytzer P, Blum A, De Herdt D, Dubois D; Trial Investigators. Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2004 Jul 15;20(2):181-8. doi: 10.1111/j.1365-2036.2004.01999.x.

Reference Type RESULT

PMID: 15233698 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR003121

Identifier Type: -

Identifier Source: org_study_id