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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079050
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
American University of Beirut Medical Center

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.


Condition or disease Intervention/treatment Phase
GERD Proton Pump Inhibitor Drug: Dexlansoprazole 60 MG Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

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 Name: Dexilant 60 MG




Primary Outcome Measures :
  1. Heartburn Relief [ Time Frame: 1 month ]
    The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079050


Locations
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Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Takeda
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03079050    
Other Study ID Numbers: IM.AS1.48
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heartburn
Signs and Symptoms, Digestive
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action