Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv
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)
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2002
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedJanuary 24, 2011
January 1, 2011
3 months
February 21, 2008
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
Every 10 days
Secondary Outcomes (3)
To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.
Post Day 10
To compare maximum acid output when switching between Oral and IV adminstration of Nexium
Post Day 10
Safety assessment via adverse event recording.
At each visit
Study Arms (2)
1
EXPERIMENTAL20mg oral
2
EXPERIMENTAL20mg IV
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 29, 2008
Study Start
July 1, 2002
Primary Completion
October 1, 2002
Study Completion
October 1, 2002
Last Updated
January 24, 2011
Record last verified: 2011-01