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NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206180
First received: September 15, 2005
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
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 ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
 Deglutition Disorders
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013