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

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.

Study Overview

• Status: Completed
• Conditions: GERD; Proton Pump Inhibitor
• Intervention / Treatment: Drug: Dexlansoprazole 60 MG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut - Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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 Names: Dexilant 60 MG

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Collaborators: Takeda

Publications and helpful links

General Publications

• Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
• Behm BW, Peura DA. Dexlansoprazole MR for the management of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2011 Aug;5(4):439-45. doi: 10.1586/egh.11.37.
• Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
• Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.
• Solem C, Mody R, Stephens J, Macahilig C, Gao X. Mealtime-related dosing directions for proton-pump inhibitors in gastroesophageal reflux disease: physician knowledge, patient adherence. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):144-53. doi: 10.1331/JAPhA.2014.13117.
• Abbas Z. Gastrointestinal health in Ramadan with special reference to diabetes. J Pak Med Assoc. 2015 May;65(5 Suppl 1):S68-71.
• Rimmani HH, Rustom LBO, Rahal MA, Shayto RH, Chaar H, Sharara AI. Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan. Dig Dis. 2019;37(3):188-193. doi: 10.1159/000496091. Epub 2019 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: IM.AS1.48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes