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

Gastroesophageal Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626262
• Other study ID #: D9615C00014
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2008
• Last updated: January 21, 2011
• Start date: July 2002
• Est. completion date: October 2002

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole
Oral and Intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.		Post Day 10
Secondary	To compare maximum acid output when switching between Oral and IV adminstration of Nexium		Post Day 10
Secondary	Safety assessment via adverse event recording.		At each visit