Clinical trial NCT00241501: Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
Official title: A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
* Patients must be male or female between the age of 12 and 17 years, inclusive.
* Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.

Exclusion Criteria:

* Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
* Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
* Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.

Primary outcomes:
measure: To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
measure: 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
Secondary outcomes:
measure: To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
measure: - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
measure: - Assessment of changes from baseline in Physician Global Assessment.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Waltham
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: St Paul
country: United States
facility: Research Site
state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Binghamton
country: United States
facility: Research Site
state: New York
city: Bronx
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Johnson City
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Parkdale
country: Canada
facility: Research Site
state: Prince Edward Island
city: Lille
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Genova
country: Italy
facility: Research Site
state: GE
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84.