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
  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:


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 April 17, 2014