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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079050
• Other study ID #: IM.AS1.48
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2017
• Last updated: September 14, 2017
• Start date: February 27, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: February 2017
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• GERD
• Heartburn
• Proton Pump Inhibitor

Intervention

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

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Takeda

Country where clinical trial is conducted

Lebanon, 

References & Publications (6)

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heartburn Relief	The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.	1 month
Secondary	Days with partial relief of heartburn symptoms	Days with partial relief of heartburn symptoms	1 month
Secondary	Days with relief of nocturnal heartburn symptoms	Days with relief of nocturnal heartburn symptoms	1 month
Secondary	Improvement in sleep qualit	The number of nocturnal sleeping hours will be assessed daily	1 month
Secondary	Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg	"Side effects and tolerability" Questionnaire	1 month