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

NCT03079050 | Completed Phase 4 FDA Drug

• 1 other identifier: IM.AS1.48
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Heartburn Relief

  The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.

  1 month

Secondary Outcomes (4)

• Days with partial relief of heartburn symptoms

  1 month

• Days with relief of nocturnal heartburn symptoms

  1 month

• Improvement in sleep qualit

  1 month

• Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg

  1 month

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Dexlansoprazole 60 MG DRUG

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

Also known as: Dexilant 60 MG

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Takeda: collaborator

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Lebanon

Location

Related Publications (7)

• 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.

  PMID: 21780890 BACKGROUND

• 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.

  PMID: 21224838 BACKGROUND

• 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.

  PMID: 22155561 BACKGROUND

• 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.

  PMID: 24632930 BACKGROUND

• 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.

  PMID: 18789939 BACKGROUND

• Abbas Z. Gastrointestinal health in Ramadan with special reference to diabetes. J Pak Med Assoc. 2015 May;65(5 Suppl 1):S68-71.

  PMID: 26013794 BACKGROUND

• 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.

  PMID: 30625462 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 14, 2017
• Study Start: February 27, 2017
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)