Gastric UlcerPhase 3NCT00542789
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
A Phase 3 study testing Esomeprazole in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 39 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 39 sitesJapan
- Study dates
- Aug 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical history of gastric and/or duodenal ulcer
- A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Who cannot join
- Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- History of esophageal, gastric or duodenal surgery
- Having severe liver disease or chronic renal disease
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Japan39 sites
Research Site
Akashi, HYOGOi
Research Site
Beppu, Oita Prefecture
Research Site
Chiisagata, Nagano
Research Site
Chiryū, Aichi-ken
Research Site
Chiyoda City, Tokyo
Research Site
Fukuroi, Shizuoka
Research Site
Hamamatsu, Shizuoka
Research Site
Hirakata, Osaka
Research Site
Hitachi, Ibaragi
Research Site
Ibara, Okayama-ken
Research Site
Itami, Hyōgo
Research Site
Izunokuni, Shizuoka
Research Site
Kawagoe, Saitama
Research Site
Kōtari, Kyoto
Research Site
Koto, Hyōgo
Research Site
Koto, Tokyo
Research Site
Kyoto, Kyoto
Research Site
Maikinohara, Shizuoka
Research Site
Matsumoto, Nagano
Research Site
Miyaodai, Fukuoka
Research Site
Morioka, Iwate
Research Site
Musashimurayama, Tokyo
Research Site
Nagano, Nagano
Research Site
Nishinomiya, Hyōgo
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Sagamihara, Kanagawa
Research Site
Saitama, Saitama
Research Site
Sakai, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Sasebo, Nagasaki
Research Site
Seto, Aichi-ken
Research Site
Shimotsuke, Tochigi
Research Site
Shizuoka, Shizuoka
Research Site
Suita, Osaka
Research Site
Takatsuki, Osaka
Research Site
Yaizu, Shizuoka
Research Site
Yokohama, Kanagawa
Research Site
Yotukaido, Chiba
About this study
Official title: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
- Being tested
- Esomeprazole, Placebo
- Keywords
- gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Arthritis, Rheumatoid, Osteoarthritis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
20mg once daily oral
PlaceboDrug
once daily oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | Esomeprazole 20 mg Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
Measured: each visit up to 24 weeks
Secondary outcomes (2)
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Measured: up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startAug 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric UlcerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naotsugu Oyama, Study director, AstraZeneca Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542789
- Sponsor's protocol ID
- D961HC00001
- Status last verified
- May 2010
- First submitted
- 11 Oct 2007
- Last updated
- 28 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.
PubMed 22591121
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
- ClinicalTrials.gov ID
- NCT00542789
- Acronym / sponsor ID
- D961HC00001
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
- Keywords
- gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Posted 28 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: EsomeprazoleEsomeprazole 20 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical history of gastric and/or duodenal ulcer
- A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Key exclusion criteria (3 listed)
- Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- History of esophageal, gastric or duodenal surgery
- Having severe liver disease or chronic renal disease
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 once daily oral | Drug | 2 |
| Placeboonce daily oral | Drug | 1 |
Primary outcome
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time frame: each visit up to 24 weeks
The absence of gastric and/or duodenal ulcer throughout the treatment period
2 secondary outcomes
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time frame: up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22591121Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.
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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.
Naotsugu Oyama study director
AstraZeneca Japan
39 sites in 1 country: 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 Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 39 sites in Japan.
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 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period (time frame: each visit up to 24 weeks). 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 NCT00542789, 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 28 May 2010.