GERDPhase 3NCT00427635

Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

A Phase 3 study testing Esomeprazole in people with GERD, run by AstraZeneca at 3 sites in 3 countries.

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 assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients. Read more about this study

Who is it for?: Ages Up to 1 month
Conditions the study is for: GERD
What is being tested?: Esomeprazole
How many people: 32 participants
Where: 3 sitesin 3 countries
Study dates: Oct 2006to Apr 2009
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 Up to 1 month
All sexes
No healthy volunteers
Child

Who may be able to join

Full-term or gestational age >/= 28 to 44 weeks
In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Who cannot join

Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
Patients with any condition that may require surgery during the course of the study
Patients with acute respiratory distress within 72 hours prior to enrollment

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Australia1 site

Research Site
North Adelaide

Other trials in Australia

Germany1 site

Research Site
Aachen

Other trials in Germany

United Kingdom1 site

Research Site
Sheffield

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age

Conditions: GERD
Being tested: Esomeprazole
Keywords: neonates, infants, GERD, reflux
Medical subject headings: Gastroesophageal Reflux

What participants receive

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

EsomeprazoleDrug

What is being measured

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

Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
Measured: Baseline and end of treatment (10-14 days)

Secondary outcomes (11)

Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
Number of reflux episodes based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Acidic Reflux Episodes
Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Weakly Acidic Reflux Episodes
Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Non Acidic Reflux Episodes
Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Liquid Acidic Reflux Episodes
Number of reflux episodes based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
Number of reflux episodes based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Bolus Clearance Time
Based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Acid Clearance Time
Based on 24-hour impedance monitoring data
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH<4.0
Percentage time with pH<4 during 24-hour pH monitoring
Measured: Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH Within 4.0-6.9
Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Measured: Baseline and end of treatment (10-14 days)

Timeline

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

Oct 2006Apr 2009

First posted29 Jan 2007 (estimated)
Study startOct 2006
Study completionApr 2009

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 (1)Papers the sponsor has linked to this study.
Other trials for GERDStudies 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
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00427635
Sponsor's protocol ID: D9614C00004
Status last verified: Dec 2010
First submitted: 25 Jan 2007
Last updated: 20 Dec 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.
PubMed 23800403

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 GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
ClinicalTrials.gov ID: NCT00427635
Acronym / sponsor ID: D9614C00004
Conditions: GERD
Keywords: neonates, infants, GERD, reflux
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2006
Study completion: Apr 2009 (actual)
First posted: 29 Jan 2007 (estimated)
Results: Posted 19 May 2010

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: Parallel groups
Masking: Double blind

Who may qualify

Ages: Up to 1 month
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Full-term or gestational age >/= 28 to 44 weeks
In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Key exclusion criteria (3 listed)

Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
Patients with any condition that may require surgery during the course of the study
Patients with acute respiratory distress within 72 hours prior to enrollment

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	Drug	–

Primary outcome

Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
Time frame: Baseline and end of treatment (10-14 days)
The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.

11 secondary outcomes

Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Acidic Reflux Episodes
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Weakly Acidic Reflux Episodes
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Non Acidic Reflux Episodes
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Liquid Acidic Reflux Episodes
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Bolus Clearance Time
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Acid Clearance Time
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH<4.0
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH Within 4.0-6.9
Time frame: Baseline and end of treatment (10-14 days)

Results and safety

Results posted to the registry on 19 May 2010, 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	26	25
Placebo	26	26

Primary outcome: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring

Time frame: Baseline and end of treatment (10-14 days). Mean (Standard Deviation). Unit: Mean Number of Events

Measure	Esomeprazole n = 25	Placebo n = 26
Value	-28.01 (77.70)	-24.79 (44.25)

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	0 of 6 (0%)	6 of 6 (100%)	Not reported
Placebo	3 of 7 (42.9%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23800403Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.

Related trials for 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.

Marta Illueca, MD study director

AstraZeneca

Per Lundborg, MD study director

AstraZeneca

Kathryn Collison, MPH, MT(ASCP) study director

AstraZeneca

3 sites in 3 countries: 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 GERD, run by AstraZeneca at 3 sites in 3 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 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia, Germany, United Kingdom. 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 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 19 May 2010). 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 From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (time frame: Baseline and end of treatment (10-14 days)). 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 NCT00427635, 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 20 Dec 2010.