Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy

March 29, 2010 updated by: Chinese University of Hong Kong

Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.

On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.

The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.

Study Overview

Status

Completed

Conditions

Gastroesophageal Reflux Disease

Intervention / Treatment

Drug: Esomeprazole

Study Type

Interventional

Enrollment (Anticipated)

244

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Endoscopy Centre, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months

Exclusion Criteria:

Erosive esophagitis
Concomitant peptic ulcer disease
Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
Pregnant or lactating female
Illiterate patient (who cannot administer questionnaire)
Known hypersensitivity to PPI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment failure Time Frame: 26 Weeks	26 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Time Frame: 1 year	1 year
Symptom score Time Frame: 26 weeks	26 weeks
Number of days off treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria