NCT00468559

Brief Summary

The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
4 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 30, 2007

Results QC Date

June 3, 2009

Last Update Submit

May 6, 2014

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

pediatricsneonates

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)

    Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.

    Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)

Secondary Outcomes (12)

  • Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)

    Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)

  • Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).

    Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)

  • Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)

    Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)

  • Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)

    Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained

  • Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)

    Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained

  • +7 more secondary outcomes

Study Arms (3)

Open Label Esomeprazole

EXPERIMENTAL

This is an open label, run-in phase. All patients received Esomeprazole.

Drug: Open Label Run In Esomeprazole

Double Blind Esomeprazole

EXPERIMENTAL

This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

Drug: Double Blind Esomeprazole

Double Blind Placebo

PLACEBO COMPARATOR

This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

Drug: Double Blind Placebo

Interventions

Open Label Run In EsomeprazoleDRUG

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

Open Label Esomeprazole
Double Blind EsomeprazoleDRUG

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

Double Blind Esomeprazole
Double Blind PlaceboDRUG

Double Blind Placebo

Double Blind Placebo

Eligibility Criteria

Age1 Month - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
  • patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

You may not qualify if:

  • patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
  • patients with a history of acute life-threatening event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Phoenix, Arizona, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Park Ridge, Illinois, United States

Location

Research Site

Louisville, Kentucky, United States

Location

Research Site

Marrero, Louisiana, United States

Location

Research Site

Newton, Massachusetts, United States

Location

Research Site

Southfield, Michigan, United States

Location

Research Site

Las Vegas, Nevada, United States

Location

Research Site

Brooklyn, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Akron, Ohio, United States

Location

Research Site

Dayton, Ohio, United States

Location

Research Site

Chattanooga, Tennessee, United States

Location

Research Site

Roanoke, Virginia, United States

Location

Research Site

Lille, France

Location

Research Site

Paris, France

Location

Research Site

Bochum, Germany

Location

Research Site

Greifswald, Germany

Location

Research Site

Nurberg, Germany

Location

Research Site

Potsdam, Germany

Location

Research Site

Wuppertal, Germany

Location

Research Site

Bialystok, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Wroclaw, Poland

Location

Related Publications (3)

  • Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.

    PMID: 26422097DERIVED

  • Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.

    PMID: 26121349DERIVED

  • Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.

    PMID: 22241513DERIVED

Related Links

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Marta Ilueca

    AstraZeneca

    STUDY DIRECTOR

  • Jennifer Heckman

    AstraZeneca

    STUDY DIRECTOR

  • Jill McGuinn

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 2, 2014

Results First Posted

June 2, 2014

Record last verified: 2014-04

Locations

DE(5)US(14)FR(2)PL(4)