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A phase IV, non-randomized, multicenter, open-label, uncontrolled, multi-country study was carried to investigate the safety and efficacy of dexlansoprazole modified-release in individuals suffering from erosive esophagitis and non-erosive reflux disease (NERD).
In gastroesophageal reflux disease (GERD) subjects,
dexlansoprazole modified-release therapy depicts a positive efficacy and safety
profile to treat both daytime and nighttime acid regurgitation and heartburn
symptoms.
A phase IV, non-randomized,
multicenter, open-label, uncontrolled, multi-country study was carried to
investigate the safety and efficacy of dexlansoprazole modified-release in
individuals suffering from erosive esophagitis and non-erosive reflux disease
(NERD).
The trial enrolled 296 Asian participants (age ≥ 20 years)
having typical GERD symptoms for at least six months and underwent endoscopy.
Considering the endoscopic outcomes, participants were allocated to either (i)
NERD arm (n=208): Participants received dexlansoprazole modified-release 30 mg
once daily for four weeks, or (ii) EE arm (n=88): Participants received
dexlansoprazole modified-release 60 mg once daily for eight weeks. The
percentage of days that individuals did not witness any 24-hour acid
regurgitation or heartburn was the major outcome.
The therapy showed good tolerability with a low incidence of treatment-associated adverse events in both groups. During the therapeutic period, the median percentage of days that individuals did not witness any 24-hour and nighttime acid regurgitation or heartburn in both arms is shown in the table below:
Management of GERD patients with
dexlansoprazole modified-release is effective and safe to relieve heartburn and
acid regurgitation symptoms.
Journal of Neurogastroenterology and Motility
Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole
Justin C Y Wu et al.
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