Gastric UlcerPhase 3NCT00595517
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
A Phase 3 study testing Esomeprazole 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 3 sites in Japan.
Trial summary
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value… 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 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 3 sitesJapan
- Study dates
- Oct 2007to Sep 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
3 sites in 1 country.
About this study
Official title: A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) 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 Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
- Being tested
- Esomeprazole 20 mg
- 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.
Esomeprazole 20 mgDrug
Esomeprazole 20 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 20 mg | Experimental | Esomeprazole 20 mg once daily Receives: Drug: Esomeprazole 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Measured: up to 52 weeks
Secondary outcomes (3)
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Measured: up to 4 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Measured: up to 12 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Measured: up to 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naotsugu Oyama, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595517
- Sponsor's protocol ID
- D961HC00005
- Status last verified
- Aug 2012
- First submitted
- 7 Jan 2008
- Last updated
- 14 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.
PubMed 23530709
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
- ClinicalTrials.gov ID
- NCT00595517
- Acronym / sponsor ID
- D961HC00005
- 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
- 395 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 14 Sep 2012
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 Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 20 mg | Experimental | Drug: Esomeprazole 20 mgEsomeprazole 20 mg once daily |
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 |
|---|---|---|
| Esomeprazole 20 mgEsomeprazole 20 mg once daily | Drug | Esomeprazole 20 mg |
Primary outcome
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time frame: up to 52 weeks
3 secondary outcomes
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time frame: up to 4 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time frame: up to 12 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Time frame: up to 24 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23530709Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.
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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
3 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 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 3 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 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 14 Sep 2012). 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?
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period (time frame: up to 52 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 NCT00595517, 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 14 Sep 2012.