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) - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2008

Last Updated Date

March 11, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

November 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00625495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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)

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

Drug: Esomeprazole

Study Arms / Comparison Groups

Experimental: IV Nexium
Experimental: Oral Nexium

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2002

Primary Completion Date

November 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00625495

Responsible Party

Tore Lind, MD - Nexium Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

D9615C00013

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP