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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00241514

First received: October 18, 2005

Last updated: January 20, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2005

Last Updated Date

January 20, 2011

Start Date ^ICMJE

February 2001

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00241514 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.

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 Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Official Title ^ICMJE

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

Brief Summary

This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.

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 *

Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Langstrom G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17.

* 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

334

Completion Date

February 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed informed consent.
Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.

Exclusion Criteria:

Discontinuation from study SH-NEN-0001
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.
Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00241514

Other Study ID Numbers ^ICMJE

D9617C00002, SH-NEN-0002

Has Data Monitoring Committee

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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