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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00241514
Other study ID # D9617C00002
Secondary ID SH-NEN-0002
Status Completed
Phase Phase 3
First received October 18, 2005
Last updated January 20, 2011
Start date February 2001
Est. completion date February 2003

Study information

Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 334
Est. completion date February 2003
Est. primary completion date February 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Esomeprazole


Locations

Country Name City State
Belgium Research Site Alleur
Belgium Research Site Ans
Belgium Research Site Beernem
Belgium Research Site Betekom
Belgium Research Site Bottelaere
Belgium Research Site Braine-L 'Alleud
Belgium Research Site Buizingen
Belgium Research Site Duffel
Belgium Research Site Durnal
Belgium Research Site Erembodegem
Belgium Research Site Genk
Belgium Research Site Gent
Belgium Research Site Herentals
Belgium Research Site Lambermont
Belgium Research Site Leut
Belgium Research Site Liège
Belgium Research Site Linkebeek
Belgium Research Site Maasmechelen
Belgium Research Site Massemen
Belgium Research Site Merelbeke
Belgium Research Site Natoye
Belgium Research Site Nivelles
Belgium Research Site Oud-Heverlee
Belgium Research Site Seraing
Belgium Research Site Soignies
Belgium Research Site Vorst (Brussels)
Belgium Research Site Waremme
Belgium Research Site Zoersel
Belgium Research Site Zolder
France Research Site Albens
France Research Site Angers
France Research Site Dambach La Ville
France Research Site Dommartin-les-touls
France Research Site Fontaine Les Dijon
France Research Site Gemenos
France Research Site Geste
France Research Site Husseren-wesserling
France Research Site La Regrip
France Research Site Le Pian Medoc
France Research Site Lille
France Research Site Lyon
France Research Site Maromme
France Research Site MONT DE MARSAN Cedex
France Research Site Montingy Les Metz
France Research Site Paris Cedex 10
France Research Site Saint-ouen
France Research Site Strasbourg
France Research Site Tarare
Germany Research Site Berlin
Germany Research Site Bernau
Germany Research Site Bochum
Germany Research Site Dresden
Germany Research Site Dresden-Test
Germany Research Site Erfurt
Germany Research Site Erlangen
Germany Research Site Genthin
Germany Research Site Herne
Germany Research Site Kelkheim
Germany Research Site Köln
Germany Research Site Künzing
Germany Research Site Lienen
Germany Research Site Lüdenscheid
Germany Research Site München
Germany Research Site Münster
Germany Research Site Paderborn
Germany Research Site Passau
Germany Research Site Potsdam
Germany Research Site Ratingen
Germany Research Site Regensburg
Germany Research Site Ribnitz-Damgarten
Germany Research Site Saarbrücken
Germany Research Site Salzgitter
Germany Research Site Wangen
Germany Research Site Wiesbaden
Germany Research Site Wolmirstedt
Hungary Research Site Békéscsaba
Hungary Research Site Budapest
Hungary Research Site Dunaújváros
Hungary Research Site Szentes
Hungary Research Site Szombathely
Hungary Research Site Vác
Hungary Research Site Veszprém
Spain Research Site Barcelona
Spain Research Site Getafe
Spain Research Site Guadalajara
Spain Research Site Madrid
Spain Research Site Mérida
Spain Research Site Palma de Mallorca
Spain Research Site San Sebastián(Guipuzcoa)
Spain Research Site Sevilla
Spain Research Site Torrelavega
Spain Research Site Valencia
Spain Research Site Viladecans
Spain Research Site Zaragoza
United States Research Site Anaheim California
United States Research Site Baltimore Maryland
United States Research Site Bradenton Florida
United States Research Site Clearwater Florida
United States Research Site Conyers Georgia
United States Research Site Ft. Lauderdale Florida
United States Research Site Jacksonville Florida
United States Research Site Newburgh Indiana
United States Research Site Norfolk Virginia
United States Research Site Orange California
United States Research Site San Francisco California
United States Research Site South Miami Florida
United States Research Site Tipton Pennsylvania
United States Research Site Tucson Arizona
United States Research Site Tulsa Oklahoma
United States Research Site Virginia Beach Virginia
United States Research Site West Palm Beach Florida
United States Research Site Winston-Salem North Carolina
United States Research Site Zephyr Hills Florida

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
Primary and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
Primary prevention of relapse of upper GI symptom associated with NSAID use in patients
Primary receiving daily NSAID therapy.
Secondary 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.
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