Skip to main content
OpenTrials
Completed

NCT Number: NCT00343161

Symptom Adapted Therapy in GERD Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Aiterhofen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Drug

Primary outcomes

  1. To compare the efficacy of three different long-term treatment strategies in primary care setting

  2. To compare treatments separately within different levels of symptom load according to clinical judgement at baseline

  3. Number of 'treatment failures' used as primary outcome variable.

Secondary outcomes

  1. To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load

  2. Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy

  3. To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy

  4. To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: SYMPATHY

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 22, 2006
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.