Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00444275

Purpose

To compare the efficacy of three different long-term treatment strategies in primary care setting, separately within different levels of symptom load according to clinical judgment at baseline (Visit 1) in subjects with symptoms thought to be GERD-related.

Condition	Intervention	Phase
GERD	Drug: esomeprazole (Nexium) Drug: Xolaam®	Phase IV

MedlinePlus related topics: GERD

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

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 Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks 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:

Number of 'treatment failures' within the maintenance phase

Secondary Outcome Measures:

Clinical judgment of investigator regarding the severity of GERD-related symptoms (mild, moderate, severe).
Treatment strategy of investigator at Visit 1.
Dimension scores derived from the GERD Impact Scale.
ASA medication used during acute phase

Estimated Enrollment:	6000
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).

Exclusion Criteria:

Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within last 3 months prior to Visit 1.
A history of severe esophagitis or known other complications, with alarm symptoms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444275

Locations

France
Research Site
Rouen, France

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca France Medical Director, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D9612L00111, EudraCT No: 2006-002867-19
Study First Received:	March 5, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00444275
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

Gastroesophageal Reflux Disease
Acid Reflux

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009