Clinical trial NCT00241514: Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GERD
Keywords: NSAIDs
Upper GI symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
measure: and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
measure: prevention of relapse of upper GI symptom associated with NSAID use in patients
measure: receiving daily NSAID therapy.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Zephyr Hills
country: United States
facility: Research Site
state: Florida
city: Conyers
country: United States
facility: Research Site
state: Georgia
city: Newburgh
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Tipton
country: United States
facility: Research Site
state: Pennsylvania
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Alleur
country: Belgium
facility: Research Site
city: Ans
country: Belgium
facility: Research Site
city: Beernem
country: Belgium
facility: Research Site
city: Betekom
country: Belgium
facility: Research Site
city: Bottelaere
country: Belgium
facility: Research Site
city: Braine-L 'Alleud
country: Belgium
facility: Research Site
city: Buizingen
country: Belgium
facility: Research Site
city: Duffel
country: Belgium
facility: Research Site
city: Durnal
country: Belgium
facility: Research Site
city: Erembodegem
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Herentals
country: Belgium
facility: Research Site
city: Lambermont
country: Belgium
facility: Research Site
city: Leut
country: Belgium
facility: Research Site
city: Linkebeek
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Maasmechelen
country: Belgium
facility: Research Site
city: Massemen
country: Belgium
facility: Research Site
city: Merelbeke
country: Belgium
facility: Research Site
city: Natoye
country: Belgium
facility: Research Site
city: Nivelles
country: Belgium
facility: Research Site
city: Oud-Heverlee
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Soignies
country: Belgium
facility: Research Site
city: Vorst (Brussels)
country: Belgium
facility: Research Site
city: Waremme
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Zolder
country: Belgium
facility: Research Site
city: Albens
country: France
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Dambach La Ville
country: France
facility: Research Site
city: Dommartin-les-touls
country: France
facility: Research Site
city: Fontaine Les Dijon
country: France
facility: Research Site
city: Gemenos
country: France
facility: Research Site
city: Geste
country: France
facility: Research Site
city: Husseren-wesserling
country: France
facility: Research Site
city: La Regrip
country: France
facility: Research Site
city: Le Pian Medoc
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Maromme
country: France
facility: Research Site
city: MONT DE MARSAN Cedex
country: France
facility: Research Site
city: Montingy Les Metz
country: France
facility: Research Site
city: Paris Cedex 10
country: France
facility: Research Site
city: Saint-ouen
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tarare
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bernau
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dresden-Test
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Genthin
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Kelkheim
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Künzing
country: Germany
facility: Research Site
city: Lienen
country: Germany
facility: Research Site
city: Lüdenscheid
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Ribnitz-Damgarten
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Salzgitter
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wolmirstedt
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Békéscsaba
country: Hungary
facility: Research Site
city: Dunaújváros
country: Hungary
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Veszprém
country: Hungary
facility: Research Site
city: Vác
country: Hungary
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Getafe
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Mérida
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: San Sebastián(Guipuzcoa)
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Torrelavega
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Viladecans
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/ar2124.