NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

This study has been completed.

First Received: September 15, 2005 Last Updated: March 25, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206180

Purpose

The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.

Condition	Intervention	Phase
Erosive Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease	Drug: esomeprazole magnesium (oral medication)	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily

Resource links provided by NLM:

MedlinePlus related topics: GERD

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.

Secondary Outcome Measures:

Secondary outcomes and the relationship to pH will also be assessed.

Estimated Enrollment:	120
Study Start Date:	June 2004
Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
Patients must have moderate to severe erosive esophagitis

Exclusion Criteria:

Significant gastrointestinal bleeding
Severe heart, lung, liver or kidney disease
Esophagitis not related to acid reflux

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206180

Show 39 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Nexium Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007 Mar 1;25(5):617-28.

Study ID Numbers:	D9612L00062
Study First Received:	September 15, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00206180 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Gastrointestinal Diseases
Ulcer
Omeprazole
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophagitis

Esophagitis, Peptic
Digestive System Diseases
Esophageal Disorder
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders

Esophagitis
Esophagitis, Peptic
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

ClinicalTrials.gov processed this record on September 11, 2009