Clinical trial NCT00468559: Phase 3/Safety & Efficacy of Esomeprazole in Infants
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: pediatrics
neonates
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-02
Enrollment: 98
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
timeFrame: Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
Secondary outcomes:
measure: Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
timeFrame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
measure: Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).
timeFrame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
measure: Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)
timeFrame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
measure: Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)
timeFrame: 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
measure: Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)
timeFrame: 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
measure: Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)
timeFrame: 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
measure: Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)
timeFrame: 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
measure: Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)
timeFrame: Open-label treatment period (2 weeks)
measure: Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)
timeFrame: Open Label phase (Screening plus two weeks)
measure: Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)
timeFrame: Open Label Phase (Screening plus two weeks)
measure: Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)
timeFrame: Open Label Phase (Screening plus two weeks)
measure: Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)
timeFrame: Open Label Phase (Screening plus two weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Marrero
country: United States
facility: Research Site
state: Louisiana
city: Newton
country: United States
facility: Research Site
state: Massachusetts
city: Southfield
country: United States
facility: Research Site
state: Michigan
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Lille Cedex
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Greifswald
country: Germany
facility: Research Site
city: Nurberg
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Marta Ilueca
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Jennifer Heckman
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Jill McGuinn
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.