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Completed

NCT Number: NCT03079050

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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Proton Pump Inhibitor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

American University of Beirut - Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Dexilant 60 MG

Primary outcomes

  1. Heartburn Relief

    Time frame: 1 month

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

Secondary outcomes

  1. Days with partial relief of heartburn symptoms

    Time frame: 1 month

    Days with partial relief of heartburn symptoms

  2. Days with relief of nocturnal heartburn symptoms

    Time frame: 1 month

    Days with relief of nocturnal heartburn symptoms

  3. Improvement in sleep qualit

    Time frame: 1 month

    The number of nocturnal sleeping hours will be assessed daily

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

    Time frame: 1 month

    "Side effects and tolerability" Questionnaire

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2017
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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