Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00241540

First received: October 18, 2005

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2005

Last Updated Date

January 21, 2011

Start Date ^ICMJE

January 2001

Primary Completion Date

August 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00241540 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy
- To assess the impact of treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Official Title ^ICMJE

Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

Brief Summary

This study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

GERD

Intervention ^ICMJE

Drug: Esomeprazole

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

808

Completion Date

August 2002

Primary Completion Date

August 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age, or older.
Capable of completing the diary card.
Ability to complete the HRQL questionnaires.
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months.
Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).

Exclusion Criteria:

Current, or history of, gastric or duodenal ulcer
Current, or history of, esophageal, gastric or duodenal surgery.
History of GERD, not associated with NSAID use.
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Belgium, France, Germany, Hungary, Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00241540

Other Study ID Numbers ^ICMJE

D9617C00001, SH-NEN-0001

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

AstraZeneca Nexium Medical Sciences Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2011

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

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