NSAID Associated Gastric UlcersPhase 3NCT00633672
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
A Phase 3 study testing Esomeprazole and Ranitidine in people with NSAID Associated Gastric Ulcers, run by AstraZeneca.
Trial summary
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSAID Associated Gastric Ulcers
- What is being tested?
- Esomeprazole and Ranitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- Other key inclusion criteria, as specified in the protocol.
Who cannot join
- History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Other conditions and criteria, as specified in the protocol.
About this study
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
- Conditions
- NSAID Associated Gastric Ulcers
- Being tested
- Esomeprazole, Ranitidine
- Keywords
- NSAID, Nexium, esomeprazole, Gastric Ulcers
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
20mg Oral tablet once daily
RanitidineDrug
Also called Zantac
150mg oral twice daily
EsomeprazoleDrug
Also called Nexium
40mg oral tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20mg Oral tablet daily Receives: Drug: Esomeprazole |
| 2 | Experimental | 40mg oral tablet daily Receives: Drug: Esomeprazole |
| 3 | Active comparator | 150mg oral twice daily Receives: Drug: Ranitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
Secondary outcomes (2)
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Measured: Assessments at week 0, week 4 and week 8
Safety and tolerability of the treatments for 8 weeks of treatment.
Measured: Assessments at week 0, week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2001
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID Associated Gastric UlcersStudies 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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paula Fernstrom, Study director, Nexium Global Product Director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633672
- Sponsor's protocol ID
- SH-NEN-0006
- Status last verified
- Jan 2011
- First submitted
- 27 Feb 2008
- Last updated
- 25 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
- ClinicalTrials.gov ID
- NCT00633672
- Acronym / sponsor ID
- SH-NEN-0006
- Conditions
- NSAID Associated Gastric Ulcers
- Keywords
- NSAID, Nexium, esomeprazole, Gastric Ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 12 Mar 2008 (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.
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Esomeprazole20mg Oral tablet daily |
| 2 | Experimental | Drug: Esomeprazole40mg oral tablet daily |
| 3 | Active comparator | Drug: Ranitidine150mg oral twice daily |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- Other key inclusion criteria, as specified in the protocol.
Key exclusion criteria (3 listed)
- History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Other conditions and criteria, as specified in the protocol.
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 |
|---|---|---|
| EsomeprazoleAlso: Nexium20mg Oral tablet once daily | Drug | 1 |
| RanitidineAlso: Zantac150mg oral twice daily | Drug | 3 |
| EsomeprazoleAlso: Nexium40mg oral tablet once daily | Drug | 2 |
Primary outcome
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
2 secondary outcomes
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Time frame: Assessments at week 0, week 4 and week 8
Safety and tolerability of the treatments for 8 weeks of treatment.
Time frame: Assessments at week 0, week 4 and week 8
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 25 Jan 2011.
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.
Paula Fernstrom study director
Nexium Global Product Director, AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole and Ranitidine in people with NSAID Associated Gastric Ulcers, run by AstraZeneca.
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 2 inclusion and 3 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 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2011.