GERDPhase 3NCT00241514
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
A Phase 3 study testing Esomeprazole in people with GERD, run by AstraZeneca at 113 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Esomeprazole
- How many people
- 334 participants
- Where
- 113 sitesin 6 countries
- Study dates
- Feb 2001to Feb 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
113 sites in 6 countries.
113 sites in 6 countries
Belgium29 sites
Research Site
Alleur
Research Site
Ans
Research Site
Beernem
Research Site
Betekom
Research Site
Bottelare
Research Site
Braine-l'Alleud
Research Site
Buizingen
Research Site
Duffel
Research Site
Durnal
Research Site
Erembodegem
Research Site
Genk
Research Site
Ghent
Research Site
Herentals
Research Site
Lambermont
Research Site
Leut
Research Site
Liège
Research Site
Linkebeek
Research Site
Maasmechelen
Research Site
Massemen
Research Site
Merelbeke
Research Site
Natoye
Research Site
Nivelles
Research Site
Oud-Heverlee
Research Site
Seraing
Research Site
Soignies
Research Site
Vorst (Brussels)
Research Site
Waremme
Research Site
Zoersel
Research Site
Zolder
Germany27 sites
Research Site
Berlin
Research Site
Bernau
Research Site
Bochum
Research Site
Cologne
Research Site
Dresden
Research Site
Dresden-Test
Research Site
Erfurt
Research Site
Erlangen
Research Site
Genthin
Research Site
Herne
Research Site
Kelkheim
Research Site
Künzing
Research Site
Lienen
Research Site
Lüdenscheid
Research Site
München
Research Site
Münster
Research Site
Paderborn
Research Site
Passau
Research Site
Potsdam
Research Site
Ratingen
Research Site
Regensburg
Research Site
Ribnitz-Damgarten
Research Site
Saarbrücken
Research Site
Salzgitter
Research Site
Wangen
Research Site
Wiesbaden
Research Site
Wolmirstedt
United States19 sites
Research Site
Anaheim, California
Research Site
Baltimore, Maryland
Research Site
Bradenton, Florida
Research Site
Clearwater, Florida
Research Site
Conyers, Georgia
Research Site
Fort Lauderdale, Florida
Research Site
Jacksonville, Florida
Research Site
Newburgh, Indiana
Research Site
Norfolk, Virginia
Research Site
Orange, California
Research Site
San Francisco, California
Research Site
South Miami, Florida
Research Site
Tipton, Pennsylvania
Research Site
Tucson, Arizona
Research Site
Tulsa, Oklahoma
Research Site
Virginia Beach, Virginia
Research Site
West Palm Beach, Florida
Research Site
Winston-Salem, North Carolina
Research Site
Zephyrhills, Florida
France19 sites
Research Site
Albens
Research Site
Angers
Research Site
Dambach-la-Ville
Research Site
Dommartin-les-touls
Research Site
Fontaine-lès-Dijon
Research Site
Gémenos
Research Site
Gesté
Research Site
Husseren-Wesserling
Research Site
La Regrip
Research Site
Le Pian-Médoc
Research Site
Lille
Research Site
Lyon
Research Site
Maromme
Research Site
Mont-de-Marsan
Research Site
Montingy Les Metz
Research Site
Paris
Research Site
Saint-Ouen
Research Site
Strasbourg
Research Site
Tarare
Spain12 sites
Research Site
Barcelona
Research Site
Getafe
Research Site
Guadalajara
Research Site
Madrid
Research Site
Mérida
Research Site
Palma de Mallorca
Research Site
San Sebastián(Guipuzcoa)
Research Site
Seville
Research Site
Torrelavega
Research Site
Valencia
Research Site
Viladecans
Research Site
Zaragoza
Hungary7 sites
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Dunaújváros
Research Site
Szentes
Research Site
Szombathely
Research Site
Vác
Research Site
Veszprém
About this study
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
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.
- Conditions
- GERD
- Being tested
- Esomeprazole
- Keywords
- NSAIDs, Upper GI symptoms
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startFeb 2001
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 334 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241514
- Sponsor's protocol ID
- D9617C00002
- Other IDs
- SH-NEN-0002
- Status last verified
- Jan 2011
- First submitted
- 18 Oct 2005
- Last updated
- 21 Jan 2011
- Results posted
- No
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. doi: 10.1186/ar2124.
PubMed 17391505
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00241514
- Acronym / sponsor ID
- D9617C00002
- Conditions
- GERD
- Keywords
- NSAIDs, Upper GI symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
- Derived from this study: PubMed 17391505Hawkey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Sciences Director, MD study director
AstraZeneca
113 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with GERD, run by AstraZeneca at 113 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in Belgium, Germany, United States, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00241514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2011.