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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00164840
• Collaborator: (none)
• Enrollment: 244
• Location: 1
• Duration (Months): 66.1
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. Treatment failure [26 Weeks]

Secondary Outcome Measures

1. Symptom score [26 weeks]

2. Quality of Life [1 year]

3. Number of days off treatment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00164840
• Other Study ID Numbers: OG Study
• First Posted: Sep 14, 2005
• Last Update Posted: Mar 30, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: GERD
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Esomeprazole

Study Results

No Results Posted as of Mar 30, 2010