NCT03079050

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

Completed Phase 4 Last updated 15 September 2017

What this trial tests

Phase 4 trial testing Dexlansoprazole 60 MG in GERD in 33 participants. Completed in 30 July 2017.

Timeline

27 February 2017

Primary endpoint
30 July 2017

30 July 2017

Quick facts

Lead sponsor	American University of Beirut Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	27 February 2017
Primary completion	30 July 2017
Estimated completion	30 July 2017
Sites	1 location across Lebanon

Drugs / interventions tested

• Dexlansoprazole 60 MG — full drug profile →

Conditions studied

• GERD — all drugs for GERD →
• Proton Pump Inhibitor — all drugs for Proton Pump Inhibitor →

Sponsor

American University of Beirut Medical Center

Who can join

Adults 18 to 75, any sex, with GERD or Proton Pump Inhibitor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan.
   Rimmani HH, Rustom LBO, Rahal MA, Shayto RH, et al · · 2019 · cited 1× · PMID 30625462 · DOI 10.1159/000496091