Symptom Adapted Therapy in GERD Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD).	Drug: esomeprazole Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)	Phase IV

MedlinePlus related topics:

GERD

ChemIDplus related topics:

Magnesium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Aluminum hydroxide Algeldrate Aluminum Magnesium trisilicate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	441
Study Start Date:	August 2006
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343161

Show 96 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Michael Höcker, MD	AstraZeneca Germany

Principal Investigator:	Joachim Labenz, MD	Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

More Information

Study ID Numbers:	D9612L00109, SYMPATHY, EudraCT-No. 2006-001316-76
First Received:	June 20, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00343161
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Nexium

Study placed in the following topic categories:

Deglutition Disorders

Esophageal Motility Disorders

Magnesium trisilicate

Digestive System Diseases

Esophageal disorder

Gastrointestinal Diseases

Omeprazole

Esophageal Diseases

Gastroesophageal Reflux

Aluminum Hydroxide

Additional relevant MeSH terms:

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Adjuvants, Immunologic

Enzyme Inhibitors

Antacids

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00343161