Symptom Adapted Therapy in GERD Patients

A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00343161

Acronym

SYMPATHY

Enrollment

441

Registered

2006-06-22

Start date

2006-08-31

Completion date

2007-08-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

Nexium

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.

Interventions

DRUGesomeprazole

DRUGGelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026