An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00242736

Purpose

The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.

Condition	Intervention	Phase
GERD	Drug: Esomeprazole	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship Between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution After 4 Weeks of Treatment

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE

Secondary Outcome Measures:

The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment.
The outcome variable will be the resolution of heartburn after 2 weeks of treatment.
The outcome variables will be the presence or absence of EE at baseline and the resolution of heartburn at the end of the 4-week treatment period.
The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline.
Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs.

Estimated Enrollment:	350
Study Start Date:	October 2005
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
Male or female, 18 to 70 years old, inclusive.
Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
Negative urine pregnancy test for females of childbearing potential.
Willingness to adhere to all protocol requirements.

Exclusion Criteria:

Previous enrollment in the present study.
Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).

Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242736

Show 25 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Nexium Medical Sciences Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Orlando RC, Monyak JT, Silberg DG. Predictors of heartburn resolution and erosive esophagitis in patients with GERD. Curr Med Res Opin. 2009 Sep;25(9):2091-102.

ClinicalTrials.gov Identifier:	NCT00242736 History of Changes
Other Study ID Numbers:	D9612L00083
Study First Received:	October 19, 2005
Last Updated:	March 5, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012