Symptom Adapted Therapy in GERD Patients

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT00343161
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-21
• Study First Posted: 2006-06-22
• Study Start: 2006-08
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

Inclusion Criteria

• Signed informed consent
• Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria

• Clinical GERD diagnosis/treatment within last 3 month
• History of severe esophagitis (i.e. LA grade C or D)
• Previous anti-reflux surgery
• History of drug abuse
• Female patients who are pregnant or lactating or at risk of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of three different long-term treatment strategies in primary care setting
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Number of 'treatment failures' used as primary outcome variable.

Secondary Outcome Measures

Name	Time	Method
To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale

Trial Locations

Locations (2)

Reseach Site; 🇩🇪 Urspringen, Germany

Research Site; 🇩🇪 Zwickau, Germany