Gastroesophageal Reflux Disease (GERD)REMAINNCT00795093
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
An observational study of Gastroesophageal Reflux Disease (GERD), run by AstraZeneca at 53 sites in United States.
Trial summary
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- How many people
- 552 participants
- Where
- 53 sitesUnited States
- Study dates
- Nov 2008to Jan 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Who may be able to join
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in US English, and able to comply with study requirements
Who cannot join
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Involvement in the planning or conduct of the study
- Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Research Site
Aliquippa, Pennsylvania
Research Site
Altamonte Springs, Florida
Research Site
Atco, New Jersey
Research Site
Athens, Tennessee
Research Site
Austin, Texas
Research Site
Beachwood, Ohio
Research Site
Belleville, Illinois
Research Site
Cary, North Carolina
Research Site
Charleston, South Carolina
Research Site
Cocoa, Florida
Research Site
Columbus, Georgia
Research Site
Concord, California
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
DeFuniak Springs, Florida
Research Site
Elkin, North Carolina
Research Site
Fair Lawn, New Jersey
Research Site
Florissant, Missouri
Research Site
Irving, Texas
Research Site
Jefferson City, Missouri
Research Site
Lancaster, California
Research Site
Largo, Florida
Research Site
Leeds, Alabama
Research Site
Los Banos, California
Research Site
Maitland, Florida
Research Site
Metaire, Louisiana
Research Site
Miami, Florida
Research Site
Mishawaka, Indiana
Research Site
Naples, Florida
Research Site
New Bern, North Carolina
Research Site
Newark, Delaware
Research Site
Ocala, Florida
Research Site
Orlando, Florida
Research Site
Palm Harbor, Florida
Research Site
Peonia, Florida
Research Site
Pheonix, Arizona
Research Site
Philadelphia, Pennsylvania
Research Site
Prince Frederick, Maryland
Research Site
Roswell, Georgia
Research Site
Royston, Georgia
Research Site
San Antonio, Texas
Research Site
San Marcos, Texas
Research Site
Snellville, Georgia
Research Site
Solana Beach, California
Research Site
Southlake, Texas
Research Site
Stanley, North Carolina
Research Site
Statesville, North Carolina
Research Site
Tampa, Florida
Research Site
Towson, Maryland
Research Site
Tucson, Arizona
Research Site
Vandalia, Ohio
Research Site
Warwick, Rhode Island
Research Site
West Jordan, Utah
About this study
Official title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, PPI, partial responders
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 552 GERD patients, partial responders to PPI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use
Measured: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Utility values
Measured: Collected at enrollment visit and at 6 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Investigators
- Meg Good, Principal investigator, i3 InnovusMarie Sundin, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795093
- Sponsor's protocol ID
- D9120N00005
- Acronym
- REMAIN
- Status last verified
- May 2010
- First submitted
- 20 Nov 2008
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
- ClinicalTrials.gov ID
- NCT00795093
- Acronym / sponsor ID
- REMAIN / D9120N00005
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, PPI, partial responders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Nov 2008 (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 describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –552 GERD patients, partial responders to PPI treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Key inclusion criteria (4 listed)
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in US English, and able to comply with study requirements
Key exclusion criteria (3 listed)
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Involvement in the planning or conduct of the study
- Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use
Time frame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Utility values
Time frame: Collected at enrollment visit and at 6 month follow-up.
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 May 2010.
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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.
Meg Good principal investigator
i3 Innovus
Marie Sundin study director
AstraZeneca
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD), run by AstraZeneca at 53 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 4 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 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 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.
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?
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use (time frame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)). The study lists 2 primary outcomes in all. 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 11 May 2010; AzTrials last refreshed its copy on 7 Nov 2026.