Investigation Drug Study to Assess the Efficacy and Safety of NEXIUM for Treating Erosive Esophagitis
A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
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Clinical Trial Information
Trial Contact: Tilme, Linda; Perez, Ivana; Beltran, Yajira
Trial Phone: 321.843.5278 ; 321-841-9772 ; 321.841.7619
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IRB No: 21.163.10
Protocol Abbrev: NEXIUM - D9612C09998
Principal Investigator: Khaled Bittar, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: D9612C09998
Treatment: Drug: Nexium (esomeprazole)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04759833
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Objective
To assess the efficacy and safety of NEXIUM for the maintenance of healing of EE in pediatric patients 1 to 11 years of age
To assess the efficacy and safety of NEXIUM for the healing of EE in pediatric patients 1 to 11 years of age
To assess symptoms during the 16-week maintenance phase -
Key Eligibility
Patients 1 to 11 years of age must have a history of GERD for at least 3 months before the start of study treatment in the healing phase
