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

NCT00164840 | Completed Phase 3

• 1 other identifier: OG Study
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  26 Weeks

Secondary Outcomes (3)

• Symptom score

  26 weeks

• Quality of Life

  1 year

• Number of days off treatment

Interventions

Esomeprazole DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Justin CY WU, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 30, 2010

Record last verified: 2010-03

Locations

CN (1)