GERDPhase 4NCT00242736
An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
A Phase 4 study testing Esomeprazole in people with GERD, run by AstraZeneca at 25 sites in United States.
Trial summary
The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- Esomeprazole
- How many people
- 350 participants
- Where
- 25 sitesUnited States
- Study dates
- Oct 2005to Jan 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
- Male or female, 18 to 70 years old, inclusive.
- Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
- Negative urine pregnancy test for females of childbearing potential.
- Willingness to adhere to all protocol requirements.
Who cannot join
- Previous enrollment in the present study.
- Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
- Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
- Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
- Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
- A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
Show all 9Show fewer
- Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
- Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).
- Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Research Site
Alabaster, Alabama
Research Site
Anaheim, California
Research Site
Arlington Heights, Illinois
Research Site
Austin, Texas
Research Site
Chattanooga, Tennessee
Research Site
Christiansburg, Virginia
Research Site
Elkin, North Carolina
Research Site
Hollywood, Maryland
Research Site
Houston, Texas
Research Site
Knoxville, Tennessee
Research Site
Miami, Florida
Research Site
Mobile, Alabama
Research Site
New Orleans, Louisiana
Research Site
Norfolk, Virginia
Research Site
North Little Rock, Arkansas
Research Site
Ocoee, Florida
Research Site
Ogden, Utah
Research Site
Oklahoma City, Oklahoma
Research Site
Orange, California
Research Site
Salt Lake City, Utah
Research Site
Shreveport, Louisiana
Research Site
Tampa, Florida
Research Site
Torrance, California
Research Site
Tucson, Arizona
Research Site
Zephyrhills, Florida
About this study
Official title: An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship Between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution After 4 Weeks of Treatment
The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.
- Conditions
- GERD
- Being tested
- Esomeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE
Secondary outcomes (5)
The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment.
The outcome variable will be the resolution of heartburn after 2 weeks of treatment.
The outcome variables will be the presence or absence of EE at baseline and the resolution of heartburn at the end of the 4-week treatment period.
The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline.
Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startOct 2005
- Study completionJan 2006
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 GERDStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242736
- Sponsor's protocol ID
- D9612L00083
- Status last verified
- Mar 2009
- First submitted
- 19 Oct 2005
- Last updated
- 6 Mar 2009
- Results posted
- No
Publications
Orlando RC, Monyak JT, Silberg DG. Predictors of heartburn resolution and erosive esophagitis in patients with GERD. Curr Med Res Opin. 2009 Sep;25(9):2091-102. doi: 10.1185/03007990903080931.
PubMed 19601705
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship Between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution After 4 Weeks of Treatment
- ClinicalTrials.gov ID
- NCT00242736
- Acronym / sponsor ID
- D9612L00083
- Conditions
- GERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 21 Oct 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 evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
- Male or female, 18 to 70 years old, inclusive.
- Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
- Negative urine pregnancy test for females of childbearing potential.
- Willingness to adhere to all protocol requirements.
Key exclusion criteria (9 listed)
- Previous enrollment in the present study.
- Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
- Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
- Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
- Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
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 | Drug | – |
Primary outcome
The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE
5 secondary outcomes
The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment.
The outcome variable will be the resolution of heartburn after 2 weeks of treatment.
The outcome variables will be the presence or absence of EE at baseline and the resolution of heartburn at the end of the 4-week treatment period.
The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline.
Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs.
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 6 Mar 2009.
- Derived from this study: PubMed 19601705Orlando RC, Monyak JT, Silberg DG. Predictors of heartburn resolution and erosive esophagitis in patients with GERD. Curr Med Res Opin. 2009 Sep;25(9):2091-102. doi: 10.1185/03007990903080931.
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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 Nexium Medical Sciences Director, MD study director
AstraZeneca
25 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 in people with GERD, run by AstraZeneca at 25 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 5 inclusion and 9 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 6 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 25 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?
The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE. 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 NCT00242736, 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 6 Mar 2009.