A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

This study has been completed.

First Received: March 18, 2008 Last Updated: March 25, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641602

Purpose

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

Condition	Intervention	Phase
Erosive Esophagitis	Drug: Esomeprazole Drug: Lansoprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.

Resource links provided by NLM:

MedlinePlus related topics: Heartburn

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale. [ Time Frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) ]

Secondary Outcome Measures:

1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE. [ Time Frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) ]
1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary. [ Time Frame: Dairy card to be completed by patient daily ]
To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE. [ Time Frame: Adverse event collection on an ongoing basis ]

Estimated Enrollment:	1000
Study Start Date:	December 2002
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nexium	Drug: Esomeprazole 40mg once daily
2: Active Comparator Prevacid	Drug: Lansoprazole 30mg once daily

Eligibility

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

Criteria

Inclusion Criteria:

Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
Confirmed Erosive Esophagitis within 1 week prior to starting the study.

Exclusion Criteria:

Any signs of gastrointestinal bleeding at the time of the starting the study.
Any previous gastric or esophageal surgery.
Various gastrointestinal diseases as listed in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641602

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	Astra Zeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	322, D9612L00046
Study First Received:	March 18, 2008
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00641602 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Erosive Esophagitis
Nexium
Heartburn

Study placed in the following topic categories:

Anti-Infective Agents
Esophagitis
Pyrosis
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases

Heartburn
Omeprazole
Lansoprazole
Esophageal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on September 10, 2009