Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00230516
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Duration (Months): 5
• Patients Per Site: 50
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Nexium; Drug: Prevacid	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers. []

Secondary Outcome Measures

1. Secondary Outcomes will compare additional efficacy and safety parameters. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants must be 18-70 years of age

• Participants can be male or female

• Women that are able to have children must have a negative pregnancy test.

Exclusion Criteria:

• Involvement in or planning of this study

• Participation in another clinical study within 28 days of this one

• For women, pregnancy or attempting to become pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Los Angeles	California	United States
2	Research Site	Oklahoma City	Oklahoma	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Nexium Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00230516
• Other Study ID Numbers: D9612L00080
• First Posted: Oct 3, 2005
• Last Update Posted: Jan 4, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by , ,: N/A this study is being conducted with healthy volunteers
• Additional relevant MeSH terms: Lansoprazole

Study Results

No Results Posted as of Jan 4, 2013