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

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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: July 2002
• Actual Primary Completion Date: October 2002
• Actual Study Completion Date: October 2002

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 20mg oral	Drug: Esomeprazole; Oral and Intravenous; Other Name: Nexium
Experimental: 2; 20mg IV	Drug: Esomeprazole; Oral and Intravenous; Other Name: Nexium

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: Every 10 days ]

Secondary Outcome Measures :

1. To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium. [ Time Frame: Post Day 10 ]
2. To compare maximum acid output when switching between Oral and IV adminstration of Nexium [ Time Frame: Post Day 10 ]
3. Safety assessment via adverse event recording. [ Time Frame: At each visit ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

AstraZeneca

Investigators

• Study Director: Paula Fernstrom; Nexium Global Product Director, AstraZeneca

More Information

• Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
• ClinicalTrials.gov Identifier: NCT00626262
• Other Study ID Numbers: D9615C00014
• First Posted: February 29, 2008
• Last Update Posted: January 24, 2011
• Last Verified: January 2011

Keywords provided by AstraZeneca:

Gastroesophageal reflux disease; Nexium; Esomeprazole; Administration methods.

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophagitis, Peptic; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Esomeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action