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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00626262
First received: February 21, 2008
Last updated: January 21, 2011
Last verified: January 2011

February 21, 2008
January 21, 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.
 
Completed
60
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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00626262
D9615C00014
No
Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
AstraZeneca
January 2011

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