Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

This study has been completed.

First Received: February 20, 2008 Last Updated: March 11, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00625495

Purpose

The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Esomeprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	An Open, Randomised Two Way Crossover Study Comparing the Effects of 40mg of Esomeprazole Adminstered Orally and Intravenously as a 3 Minute Injection on Basal and Pentrigastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:

MedlinePlus related topics: GERD

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration. [ Time Frame: Every 10 days ]

Secondary Outcome Measures:

To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium. [ Time Frame: Post Day 10 ]
To compare maximum acid output when switching between Oral and IV adminstration of Nexium [ Time Frame: Post Day 10 ]
Safety assessment via adverse event recording [ Time Frame: At each visit ]

Enrollment:	60
Study Start Date:	September 2002
Study Completion Date:	November 2002
Primary Completion Date:	November 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IV Nexium	Drug: Esomeprazole 40mg Intravenous infusion over 3 minutes
2: Experimental Oral Nexium	Drug: Esomeprazole 40mg Oral

Eligibility

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

Criteria

Inclusion Criteria:

Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis).
Body Mass Index within the limits specified in the protocol

Exclusion Criteria:

History of esophageal, duodenal or gastric surgery
History of severe liver disease.
Any other significant disease or pathology judged to be clinically significant by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625495

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	D9615C00013
Study First Received:	February 20, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00625495 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Gastroesophageal reflux disease
Nexium
Esomeprazole
Administration methods.

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
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on November 25, 2009