Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00626262

Purpose

The purpose of this study is to examine the effects of Nexium at a dose of 20mg 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

MedlinePlus related topics: GERD

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

U.S. FDA Resources

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 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

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 administration 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 ]

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

Arms	Assigned Interventions
1: Experimental 20mg oral	Drug: Esomeprazole Oral and Intravenous
2: Experimental 20mg IV	Drug: Esomeprazole Oral and Intravenous

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) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
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: NCT00626262

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	D9615C00014
Study First Received:	February 21, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00626262
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Gastroesophageal reflux disease
Nexium
Esomeprazole
Administration methods.

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009