An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Conditions
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GERD, Proton Pump Inhibitor

Intervention / Treatment
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* Drug: Dexlansoprazole 60 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 18-75 years old Fasting in Ramadan No daily PPI use Individuals willing to sign consent form Patients owning a smartphone and able to use a smartphone application Exclusion Criteria: Known erosive GERD on PPI Pregnant females Prior gastric surgery Long standing diabetes mellitus (≥10 years of disease) Frequent NSAID use (>3x/week) Morbid obesity (BMI>35) History of recent (<6 months) upper GI bleeding Patients who do not own a smartphone or who cannot use a smartphone application Known allergy to PPIs Known history of poor compliance or adherence and active psychological problems which might impact adherence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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<br>* Other names: Dexilant 60 MG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartburn Relief | The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with partial relief of heartburn symptoms | Days with partial relief of heartburn symptoms | 1 month | 
| Days with relief of nocturnal heartburn symptoms | Days with relief of nocturnal heartburn symptoms | 1 month | 
| Improvement in sleep qualit | The number of nocturnal sleeping hours will be assessed daily | 1 month | 
| Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg | Side effects and tolerability Questionnaire | 1 month |