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OpenTrials
Completed

NCT Number: NCT00241501

Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

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.

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Mount Pearl, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole (Nexium)

Drug

Primary outcomes

  1. To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients

  2. 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G

Secondary outcomes

  1. 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

  2. - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.

  3. - Assessment of changes from baseline in Physician Global Assessment.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2005
First posted
Oct 19, 2005
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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