An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
Status:
Completed
Trial end date:
2017-07-30
Target enrollment:
Participant gender:
Summary
Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved
drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1.
Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet
needs that may accompany traditional proton pump inhibitors, with two separate pH-depended
release phases, the first in the proximal duodenum and the second in the more distal small
intestine. This dual release system extends the plasma concentration and pharmacodynamics
effects beyond those of single-release PPIs, allowing for dosing at any time of the day
without regard to meals 1. A study conducted by Fass et al. has shown that the use of
dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective
than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and
consequently improving work productivity, sleep quality and quality of life 2.
Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove
beneficial in optimizing the management of GERD and the associated burdens that often surface
after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep
quality.