Gastroesophageal Reflux DiseasePhase 4NCT00410592
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
A Phase 4 study testing Esomeprazole 40mg, Pantoprazole 40mg and Lansoprazole 30mg in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 8 sites in 2 countries.
Trial summary
This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole 40mg, Pantoprazole 40mg and Lansoprazole 30mg
- How many people
- 90 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2006to May 2007
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Males and females ages 18-69 who are of Hispanic origin
- Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months
Who cannot join
- Female patients who are pregnant or breastfeeding
- Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
- Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Research Site
Anaheim, California
Research SIte
Chapel Hill, North Carolina
Research Site
Chicago, Illinois
Research Site
Houston, Texas
Research Site
Miami, Florida
Research Site
Orange, California
Research Site
San Diego, California
About this study
Official title: A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD
This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole 40mg, Pantoprazole 40mg, Lansoprazole 30mg
- Keywords
- GERD, acid reflux, heartburn, PPI, Hispanic
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mgDrug
Pantoprazole 40mgDrug
Lansoprazole 30mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.
Secondary outcomes (3)
Compare nocturnal intragastric pH in Hispanic patients with GERD
Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startOct 2006
- Study completionMay 2007
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 Gastroesophageal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marta Illueca, MD, Study director, AstraZenecaKathryn Collison, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410592
- Sponsor's protocol ID
- D9612L00106
- Status last verified
- Mar 2009
- First submitted
- 12 Dec 2006
- Last updated
- 11 Mar 2009
- Results posted
- No
Publications
Morgan D, Pandolfino J, Katz PO, Goldstein JL, Barker PN, Illueca M. Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole. Aliment Pharmacol Ther. 2010 Jul;32(2):200-8. doi: 10.1111/j.1365-2036.2010.04335.x. Epub 2010 Apr 23.
PubMed 20456300
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD
- ClinicalTrials.gov ID
- NCT00410592
- Acronym / sponsor ID
- D9612L00106
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, acid reflux, heartburn, PPI, Hispanic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- May 2007 (actual)
- First posted
- 13 Dec 2006 (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.
This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Males and females ages 18-69 who are of Hispanic origin
- Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months
Key exclusion criteria (3 listed)
- Female patients who are pregnant or breastfeeding
- Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
- Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery
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 40mg | Drug | – |
| Pantoprazole 40mg | Drug | – |
| Lansoprazole 30mg | Drug | – |
Primary outcome
To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.
3 secondary outcomes
Compare nocturnal intragastric pH in Hispanic patients with GERD
Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
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 11 Mar 2009.
- Derived from this study: PubMed 20456300Morgan D, Pandolfino J, Katz PO, Goldstein JL, Barker PN, Illueca M. Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole. Aliment Pharmacol Ther. 2010 Jul;32(2):200-8. doi: 10.1111/j.1365-2036.2010.04335.x. Epub 2010 Apr 23.
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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.
Marta Illueca, MD study director
AstraZeneca
Kathryn Collison study chair
AstraZeneca
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole 40mg, Pantoprazole 40mg and Lansoprazole 30mg in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 8 sites in 2 countries.
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 3 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 11 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 8 sites in United States, Puerto Rico. 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 compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.. 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 NCT00410592, 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 11 Mar 2009.