Gastroesophageal Reflux DiseasePhase 4NEONNCT00734097

A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

A Phase 4 study testing Esomeprazole 40 mg, Physical Exam and Quality of Life Questionnaires in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 10 sites in 4 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastroesophageal Reflux Disease
What is being tested?: Esomeprazole 40 mg, Physical Exam and Quality of Life Questionnaires
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 314 participants
Where: 10 sitesin 4 countries
Study dates: Nov 2007to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
informed consent
over 18 years of age

Who cannot join

Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
More than 1 other course of PPI treatment in the previous 12 month
previous use of esomeprazole
presence of alarm symptoms

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

Chile3 sites

Research Site
Santiago
Research Site
Temuco
Research Site
Viña del Mar

Other trials in Chile

Colombia3 sites

Research Site
Barranquilla
Research Site
Bogotá
Research Site
Medellín

Other trials in Colombia

Venezuela3 sites

Research Site
Barquisimeto
Research Site
Caracas
Research Site
San Cristóbal

Other trials in Venezuela

Argentina1 site

Research Site
Buenos Aires

Other trials in Argentina

About this study

Official title: An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

Conditions: Gastroesophageal Reflux Disease
Being tested: Esomeprazole 40 mg, Physical Exam, Quality of Life Questionnaires, pregnancy test, if applicable
Keywords: heartburn, reflux, proton, pump, inhibitor
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 40 mgDrug
Also called Nexium
Once a day
Physical ExamProcedure or surgery
every visit
Quality of Life QuestionnairesOther
every visit
pregnancy test, if applicableProcedure or surgery
as needed

Study groups in NCT00734097
Study group	Role	What they receive
Nexium 40 mgs	Experimental	Not described Receives: Drug: Esomeprazole 40 mg; Procedure: Physical Exam; Other: Quality of Life Questionnaires; Procedure: pregnancy test, if applicable

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Measured: At Baseline and 8 weeks

Secondary outcomes (11)

Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Measured: At Baseline and 4 weeks
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 8 weeks
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 4 weeks
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 4 weeks.
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 8 weeks.
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 4 weeks
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
Measured: At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 4 weeks
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 8 weeks
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Measured: At Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Oct 2008

First posted13 Aug 2008 (estimated)
Study startNov 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Single group
Masking: None (open label)
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00734097
Sponsor's protocol ID: D9612L00116
Other IDs: NEON
Acronym: NEON
Status last verified: Aug 2012
First submitted: 11 Aug 2008
Last updated: 10 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
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
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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 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
ClinicalTrials.gov ID: NCT00734097
Acronym / sponsor ID: NEON / D9612L00116
Conditions: Gastroesophageal Reflux Disease
Keywords: heartburn, reflux, proton, pump, inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 13 Aug 2008 (estimated)
Results: Posted 10 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nexium 40 mgs	Experimental	Drug: Esomeprazole 40 mg, Procedure: Physical Exam, Other: Quality of Life Questionnaires, Procedure: pregnancy test, if applicable

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
informed consent
over 18 years of age

Key exclusion criteria (4 listed)

Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
More than 1 other course of PPI treatment in the previous 12 month
previous use of esomeprazole
presence of alarm symptoms

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 40 mgAlso: NexiumOnce a day	Drug	Nexium 40 mgs
Physical Examevery visit	Procedure or surgery	Nexium 40 mgs
Quality of Life Questionnairesevery visit	Other	Nexium 40 mgs
pregnancy test, if applicableas needed	Procedure or surgery	Nexium 40 mgs

Primary outcome

Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Time frame: At Baseline and 8 weeks
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

11 secondary outcomes

Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Time frame: At Baseline and 4 weeks
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Time frame: At Baseline and 8 weeks
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Time frame: At Baseline and 4 weeks
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Time frame: At Baseline and 4 weeks.
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Time frame: At Baseline and 8 weeks.
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Time frame: At Baseline and 4 weeks
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Time frame: At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Time frame: At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Time frame: At Baseline and 4 weeks
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Time frame: At Baseline and 8 weeks
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Time frame: At Baseline and 4 weeks

Results and safety

Results posted to the registry on 10 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole 40mg, Daily	337	317

Primary outcome: Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment

Time frame: At Baseline and 8 weeks. Mean (Standard Deviation). Unit: Days per week with symptoms

Measure	Esomeprazole 40mg, Daily n = 311
Value	-3.44 (2.35)

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole 40mg, Daily	4 of 317 (1.3%)	16 of 317 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gastroesophageal Reflux Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esomeprazole 40 mg, Physical Exam and Quality of Life Questionnaires in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 10 sites in 4 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 4 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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Chile, Colombia, Venezuela, Argentina. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment (time frame: At Baseline and 8 weeks). 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 NCT00734097.

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 10 Oct 2012.