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

American University of Beirut Medical Center

Status and phase: Completed; Phase 4

Conditions: Proton Pump Inhibitor; GERD

Treatments: Drug: Dexlansoprazole 60 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03079050

IM.AS1.48

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

1

Experimental group

Description:

34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan.

Treatment:

Drug: Dexlansoprazole 60 MG