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.
To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan and who are not on daily treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
This drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms
American University of Beirut - Medical Center
Beirut, Lebanon
Heartburn Relief
The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.
Time frame: 1 month
Days with partial relief of heartburn symptoms
Days with partial relief of heartburn symptoms
Time frame: 1 month
Days with relief of nocturnal heartburn symptoms
Days with relief of nocturnal heartburn symptoms
Time frame: 1 month
Improvement in sleep qualit
The number of nocturnal sleeping hours will be assessed daily
Time frame: 1 month
Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg
"Side effects and tolerability" Questionnaire
Time frame: 1 month
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