Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of on-Demand Therapy Versus Maintenance Therapy

This study is ongoing, but not recruiting participants.

First Received: September 9, 2005 Last Updated: March 25, 2008 History of Changes

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00164840

Purpose

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. WE hypothesize that on-demand PPI treatment is as effective as maintenance PPI.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of on-Demand Therapy Versus Maintenance Therapy

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Treatment failure at 26 weeks

Secondary Outcome Measures:

Symptom score at 26 weeks, QoL at 1 year, number of days off treatment

Estimated Enrollment:	244
Study Start Date:	May 2003
Estimated Study Completion Date:	November 2008

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164840

Locations

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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Justin CY WU, MD

Chinese University of Hong Kong

More Information

No publications provided

Study ID Numbers:	OG Study
Study First Received:	September 9, 2005
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00164840 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

GERD

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on July 06, 2009