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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

City, postcode or hospital

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

Other trials in United States

About this study

Official title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

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 groups in NCT00795093
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.

Nov 2008Jan 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Gastroesophageal Reflux Disease (GERD) trials

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.

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.

Related trials for Gastroesophageal Reflux Disease (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.

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?

On the ClinicalTrials.gov record for NCT00795093.

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.