An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
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|ClinicalTrials.gov Identifier: NCT03079050|
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|GERD Proton Pump Inhibitor||Drug: Dexlansoprazole 60 MG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan|
|Actual Study Start Date :||February 27, 2017|
|Actual Primary Completion Date :||July 30, 2017|
|Actual Study Completion Date :||July 30, 2017|
34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan.
Drug: Dexlansoprazole 60 MG
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
Other Name: Dexilant 60 MG
- Heartburn Relief [ Time Frame: 1 month ]The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.
- Days with partial relief of heartburn symptoms [ Time Frame: 1 month ]Days with partial relief of heartburn symptoms
- Days with relief of nocturnal heartburn symptoms [ Time Frame: 1 month ]Days with relief of nocturnal heartburn symptoms
- Improvement in sleep qualit [ Time Frame: 1 month ]The number of nocturnal sleeping hours will be assessed daily
- Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg [ Time Frame: 1 month ]"Side effects and tolerability" Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079050
|American University of Beirut - Medical Center|