HeartburnPhase 3NEXT1NCT01370525

Efficacy of Esomeprazole in Patients With Frequent Heartburn

A Phase 3 study testing Esomeprazole in people with Heartburn, run by AstraZeneca at 10 sites in United States.

Completed

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

Trial summary

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heartburn
What is being tested?: Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 340 participants
Where: 10 sitesUnited States
Study dates: Aug 2011to Oct 2011
Phase: Phase 3
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

Males and non-pregnant ,non-lactating females 18 years or older
Experience heartburn at least 2 days a week
Having heartburn that has responded to heartburn medication
Must discontinue any current heartburn medications

Who cannot join

Having a history of erosive esophagitis verified by endoscopy
Having a history of GERD which was diagnosed by a physician
Inability to take study medication or complete the study and all study procedures
Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Research site
Cleveland, Ohio
Research site
Indianapolis, Indiana
Research site
Meridian, Idaho
Research site
Metairie, Louisiana
Research site
Mt. Pleasant, South Carolina
Research site
Omaha, Nebraska
Research site
Raleigh, North Carolina
Research site
Sacramento, California
Research site
San Antonio, Texas
Research site
Seminole, Florida

Other trials in United States

About this study

Official title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Conditions: Heartburn
Being tested: Esomeprazole
Keywords: Heartburn
Medical subject headings: Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsomeprazoleDrug
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Study groups in NCT01370525
Study group	Role	What they receive
Esomeprazole 20 mg	Experimental	Not described Receives: Drug: Esomeprazole
Placebo	Placebo comparator	Not described Receives: Drug: Esomeprazole

What is being measured

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

Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Measured: From randomisation to day 14
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Measured: From randomization to day 14

Secondary outcomes (3)

Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
Measured: From randomisation to day 14
Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Measured: From randomisation to the day 14
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.
Measured: From randomisation to day 14

Timeline

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

Aug 2011Oct 2011

First posted10 Jun 2011 (estimated)
Study startAug 2011
Primary completionOct 2011
Study completionOct 2011

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HeartburnStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01370525
Sponsor's protocol ID: D961RC00001
Acronym: NEXT1
Status last verified: Feb 2013
First submitted: 1 Jun 2011
Last updated: 14 Mar 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Peura D, Le Moigne A, Wassel H, Pollack C. Analysis of the symptom response to esomeprazole 20 mg over days 1-4 of a 14-day course of treatment for frequent heartburn: results of two randomised controlled trials. BMJ Open Gastroenterol. 2019 Jun 21;6(1):e000278. doi: 10.1136/bmjgast-2019-000278. eCollection 2019.
PubMed 31297231
Peura DA, Le Moigne A, Wassel H, Pollack C. Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials. BMC Gastroenterol. 2018 May 22;18(1):69. doi: 10.1186/s12876-018-0790-2.
PubMed 29788903
Peura D, Le Moigne A, Pollack C, Nagy P, Lind T. A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction. Postgrad Med. 2016 Aug;128(6):577-83. doi: 10.1080/00325481.2016.1203236. Epub 2016 Jul 4.
PubMed 27331882
Peura DA, Traxler B, Kocun C, Lind T. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials. Postgrad Med. 2014 Jul;126(4):33-41. doi: 10.3810/pgm.2014.07.2781.
PubMed 25141241

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

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

All Heartburn trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
ClinicalTrials.gov ID: NCT01370525
Acronym / sponsor ID: NEXT1 / D961RC00001
Conditions: Heartburn
Keywords: Heartburn
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 10 Jun 2011 (estimated)
Results: Posted 14 Mar 2013

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 investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Esomeprazole 20 mg	Experimental	Drug: Esomeprazole
Placebo	Placebo comparator	Drug: Esomeprazole

Who may qualify

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

Key inclusion criteria (4 listed)

Males and non-pregnant ,non-lactating females 18 years or older
Experience heartburn at least 2 days a week
Having heartburn that has responded to heartburn medication
Must discontinue any current heartburn medications

Key exclusion criteria (4 listed)

Having a history of erosive esophagitis verified by endoscopy
Having a history of GERD which was diagnosed by a physician
Inability to take study medication or complete the study and all study procedures
Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

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
EsomeprazoleNexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose	Drug	Esomeprazole 20 mg, Placebo

Primary outcome

Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomisation to day 14
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomization to day 14

3 secondary outcomes

Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Time frame: From randomisation to day 14
Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo
Time frame: From randomisation to the day 14
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Time frame: From randomisation to day 14

Results and safety

Results posted to the registry on 14 Mar 2013, 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	171	163
Placebo	169	158

Primary outcome: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

Time frame: From randomisation to day 14. Mean (Standard Deviation). Unit: Percentage

Measure	Esomeprazole n = 168	Placebo n = 163
Value	43.32 (34.36)	29.44 (29.83)

Population analysed: Full analysis set

Primary outcome: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

Time frame: From randomization to day 14. Mean (Standard Deviation). Unit: Percentage

Measure	Esomeprazole n = 150	Placebo n = 149
Value	44.52 (34.4)	31.25 (30.26)

Population analysed: Per-protocol analysis set

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole	0 of 168 (0%)	18 of 168 (10.7%)	Not reported
Placebo	0 of 163 (0%)	15 of 163 (9.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31297231Peura D, Le Moigne A, Wassel H, Pollack C. Analysis of the symptom response to esomeprazole 20 mg over days 1-4 of a 14-day course of treatment for frequent heartburn: results of two randomised controlled trials. BMJ Open Gastroenterol. 2019 Jun 21;6(1):e000278. doi: 10.1136/bmjgast-2019-000278. eCollection 2019.
Derived from this study: PubMed 29788903Peura DA, Le Moigne A, Wassel H, Pollack C. Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials. BMC Gastroenterol. 2018 May 22;18(1):69. doi: 10.1186/s12876-018-0790-2.
Derived from this study: PubMed 27331882Peura D, Le Moigne A, Pollack C, Nagy P, Lind T. A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction. Postgrad Med. 2016 Aug;128(6):577-83. doi: 10.1080/00325481.2016.1203236. Epub 2016 Jul 4.
Derived from this study: PubMed 25141241Peura DA, Traxler B, Kocun C, Lind T. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials. Postgrad Med. 2014 Jul;126(4):33-41. doi: 10.3810/pgm.2014.07.2781.

Related trials for Heartburn

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

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.

Tore Lind, MD study director

AstraZeneca

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole in people with Heartburn, run by AstraZeneca at 10 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 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 14 Mar 2013. 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 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Mar 2013). 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?

Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (time frame: From randomisation to day 14). 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 NCT01370525, which also lists 4 linked publications.

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 14 Mar 2013.