Erosive EsophagitisPhase 4NCT00206180
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
A Phase 4 study testing esomeprazole magnesium (oral medication) in people with Erosive Esophagitis and Reflux Esophagitis, run by AstraZeneca at 39 sites in United States.
Trial summary
The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Erosive Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease
- What is being tested?
- esomeprazole magnesium (oral medication)
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 39 sitesUnited States
- Study dates
- Jun 2004to Aug 2005
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
- Patients must have moderate to severe erosive esophagitis
Who cannot join
- Significant gastrointestinal bleeding
- Severe heart, lung, liver or kidney disease
- Esophagitis not related to acid reflux
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Research Site
Alabaster, Alabama
Research Site
Anaheim, California
Research Site
Baltimore, Maryland
Research Site
Bellevue, Washington
Research Site
Bridgeport, Connecticut
Research Site
Brooklyn, New York
Research Site
Chapel Hill, North Carolina
Research Site
Chevy Chase, Maryland
Research Site
Covington, Louisiana
Research Site
Dallas, Texas
Research Site
Decatur, Georgia
Research Site
Dinuba, California
Research Site
Duncansville, Pennsylvania
Research Site
Egg Harbor, New Jersey
Research Site
Fort Lauderdale, Florida
Research Site
Fresno, California
Research Site
Hialeah, Florida
Research Site
Jacksonville, Florida
Research Site
Jacksonville, North Carolina
Research Site
Kalamazoo, Michigan
Research Site
Knoxville, Tennessee
Research Site
Louisville, Kentucky
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
New Port Richey, Florida
Research Site
New York, New York
Research Site
North Providence, Rhode Island
Research Site
Oakbrook Terrace, Illinois
Research Site
Ogden, Utah
Research Site
Orange, California
Research Site
Passaic, New Jersey
Research Site
Pittsburgh, Pennsylvania
Research Site
Rome, Georgia
Research Site
San Diego, California
Research Site
Savannah, Georgia
Research Site
Spokane, Washington
Research Site
Troy, Michigan
Research Site
Urbana, Illinois
Research Site
Zephyrhills, Florida
About this study
Official title: A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily
The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.
- Being tested
- esomeprazole magnesium (oral medication)
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole magnesium (oral medication)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.
Secondary outcomes (1)
Secondary outcomes and the relationship to pH will also be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Study completionAug 2005
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 Erosive EsophagitisStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nexium Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206180
- Sponsor's protocol ID
- D9612L00062
- Status last verified
- Mar 2009
- First submitted
- 15 Sep 2005
- Last updated
- 26 Mar 2009
- Results posted
- No
Publications
Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007 Mar 1;25(5):617-28. doi: 10.1111/j.1365-2036.2006.03235.x.
PubMed 17305763
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily
- ClinicalTrials.gov ID
- NCT00206180
- Acronym / sponsor ID
- D9612L00062
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 21 Sep 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 decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
- Patients must have moderate to severe erosive esophagitis
Key exclusion criteria (3 listed)
- Significant gastrointestinal bleeding
- Severe heart, lung, liver or kidney disease
- Esophagitis not related to acid reflux
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 magnesium (oral medication) | Drug | – |
Primary outcome
To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.
1 secondary outcome
Secondary outcomes and the relationship to pH will also be assessed.
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 26 Mar 2009.
- Derived from this study: PubMed 17305763Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007 Mar 1;25(5):617-28. doi: 10.1111/j.1365-2036.2006.03235.x.
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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.
Nexium Medical Science Director, MD study director
AstraZeneca
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole magnesium (oral medication) in people with Erosive Esophagitis and Reflux Esophagitis, run by AstraZeneca at 39 sites in United States.
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 26 Mar 2009. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.. 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 NCT00206180, 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 26 Mar 2009.