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

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ClinicalTrials.gov Identifier: NCT00626262
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 24, 2011
Information provided by:

February 21, 2008
February 29, 2008
January 24, 2011
July 2002
October 2002   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00626262 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
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)
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).
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
Drug: Esomeprazole
Oral and Intravenous
Other Name: Nexium
  • Experimental: 1
    20mg oral
    Intervention: Drug: Esomeprazole
  • Experimental: 2
    20mg IV
    Intervention: Drug: Esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2002
October 2002   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
Not Provided
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
January 2011

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