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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

March 25, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Treatment failure at 26 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00164840 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Gastroesophageal Reflux Disease

Intervention ^ICMJE

Drug: Esomeprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

244

Estimated Completion Date

November 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00164840

Responsible Party

Study ID Numbers ^ICMJE

OG Study

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Justin CY WU, MD

Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP