Non-erosive Reflux DiseasePhase 3NCT00259077
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
A Phase 3 study testing Omeprazole in people with Non-erosive Reflux Disease, run by AstraZeneca at 26 sites in Japan.
Trial summary
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- Omeprazole
- How many people
- 270 participants
- Where
- 26 sitesJapan
- Study dates
- Oct 2003to Jul 2004
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy.
Who cannot join
- Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Japan26 sites
Study site
Asa
Study site
Beppu
Study site
Chiyoda City
Study site
Fujieda
Study site
Fukuoka
Study site
Kanagawa
Study site
Kawagucki
Study site
Kita-ku
Study site
Kitakyushu
Study site
Kyoda
Study site
Meguro City
Study site
Minato
Study site
Mitsukaidō
Study site
Miyaodai
Study site
Nagoya
Study site
Nanao
Study site
Onoda
Study site
Osaka
Study site
Ōta-ku
Study site
Ōtsu
Study site
Sapporo
Study site
Shinagawa City
Study site
Shinjuku
Study site
Tokyo
Study site
Ube
Study site
Yukuhashi
About this study
Official title: A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
- Conditions
- Non-erosive Reflux Disease
- Being tested
- Omeprazole
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
Secondary outcomes (1)
Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies 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
- 270 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tanabe Pharma Corporation
- Investigators
- AstraZeneca Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259077
- Sponsor's protocol ID
- D9587C00001
- Other IDs
- D9584L00002
- Status last verified
- Jan 2011
- First submitted
- 25 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety
- ClinicalTrials.gov ID
- NCT00259077
- Acronym / sponsor ID
- D9587C00001
- Conditions
- Non-erosive Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Tanabe Pharma Corporation
- Study start
- Oct 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 29 Nov 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.
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy.
Key exclusion criteria (1 listed)
- Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
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 |
|---|---|---|
| Omeprazole | Drug | – |
Primary outcome
To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
1 secondary outcome
Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
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 24 Jan 2011.
Related trials for Non-erosive Reflux Disease
RecruitingPhase 3
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Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
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Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
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Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
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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 Medical Science Director, MD study director
AstraZeneca
26 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 Omeprazole in people with Non-erosive Reflux Disease, run by AstraZeneca at 26 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 1 inclusion and 1 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 24 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 26 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?
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 determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.. 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 24 Jan 2011.