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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study is ongoing, but not recruiting participants.

Study NCT00164840. Last updated on March 25, 2008. Information provided by Chinese University of Hong Kong

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Treatment failure at 26 weeks

Secondary Outcome Measure ^†

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

Condition ^†

Gastroesophageal Reflux Disease

Intervention ^†

Drug: Esomeprazole

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

244

Start Date ^†

May 2003

Completion Date

November 2008

Eligibility 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China

Administrative Information Fields

NCT ID ^†

NCT00164840

Organization ID

OG Study

Secondary IDs ^††

Study Sponsor ^†

Chinese University of Hong Kong

Collaborators ^††

Investigators ^†

Principal Investigator:

Justin CY WU, MD

Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

March 2008

First Received Date ^†

September 9, 2005

Last Updated Date

March 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.