A phase II, 36-week, multicenter trial was performed to investigate efficacy and safety of dexlansoprazole (proton pump inhibitor) dual delayed-release capsule to heal erosive esophagitis and maintain healed erosive esophagitis in 62 adolescents (12–17 years) with endoscopically confirmed erosive esophagitis.
Dexlansoprazole was found to be
effective and safe to heal erosive esophagitis and maintain healed erosive
esophagitis in adolescents.
A phase II, 36-week, multicenter
trial was performed to investigate efficacy and safety of dexlansoprazole (proton pump inhibitor) dual delayed-release
capsule to heal erosive esophagitis and maintain healed erosive esophagitis in
62 adolescents (12–17 years) with endoscopically confirmed erosive esophagitis.
During the open-label healing phase, participants were given dexlansoprazole (60 mg once daily). Participants having confirmed healing at the 8th week were randomly assigned to dexlansoprazole (30 mg once daily) or placebo during the double-blind, 16-week, maintenance phase with subsequent therapy-free follow-up of ≥ 12 weeks.
The treatment-emergent adverse events (TEAEs) in ≥ 5% of participants during
the therapy was the major outcome. The proportion of individuals with the
healing of erosive esophagitis and with the maintenance of healed erosive
esophagitis were the secondary outcomes.
In total, 88% of participants attained erosive esophagitis healing, and 61.3% of participants reported a TEAE [diarrhea (6.5%), headache (12.9%), nasopharyngitis (6.5%), and oropharyngeal pain (8.1%)]. During the maintenance phase, the percentage of patients in which healing was maintained and the proportion of patients witnessing TEAEs is shown in the below table.
Dexlansoprazole-emergent side effects
included insomnia (8 %), headache (24 %), pharyngitis (12 %), abdominal pain
(12 %), bronchitis (8 %), nasopharyngitis (12 %), sinusitis (12 %), and upper
respiratory tract infection (8.0%).
Dexlansoprazole may be used as a
treatment option for erosive esophagitis in adolescents.
Digestive Diseases and Sciences
Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents
David Gremse et al.
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