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

NCT03079050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-09-15

No results posted yet for this study

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.

Conditions

  • GERD
  • Proton Pump Inhibitor

Interventions

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

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • American University of Beirut Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2017-07-30
Completion
2017-07-30
FDA Drug
Yes

Countries

  • Lebanon

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079050 on ClinicalTrials.gov