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临床试验/NCT03079050
NCT03079050已完成4 期

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

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年2月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
33
试验地点
1
主要终点
Heartburn Relief

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Experimental

34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan.

干预措施: Dexlansoprazole 60 MG (Drug)

结局指标

主要结局

Heartburn Relief

时间窗: 1 month

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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