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Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole group
Dexlansoprazole group
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited

Exclusion Criteria:

  • taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
  • coexistence of peptic ulcer or gastrointestinal malignancies
  • pregnancy
  • coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
  • previous gastric surgery
  • allergy to dexlansoprazole or esomeprazole
  • symptom score of a validated questionnaire (Chinese GERDQ) less than 12

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    dexlansoprazole group

    esomeprazole group

    Arm Description

    dexlansoprazole 60mg

    esomeprazole 40mg

    Outcomes

    Primary Outcome Measures

    Rate of complete symptom resolution (CSR)
    Evaluate the complete symptom resolution by questionnaire

    Secondary Outcome Measures

    Rate of symptom relapse
    Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life

    Full Information

    First Posted
    April 20, 2017
    Last Updated
    April 20, 2017
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03128736
    Brief Title
    Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B
    Official Title
    A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    February 28, 2016 (Actual)
    Study Completion Date
    March 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.
    Detailed Description
    A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    175 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dexlansoprazole group
    Arm Type
    Experimental
    Arm Description
    dexlansoprazole 60mg
    Arm Title
    esomeprazole group
    Arm Type
    Experimental
    Arm Description
    esomeprazole 40mg
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole group
    Other Intervention Name(s)
    Nexium
    Intervention Description
    Esomeprazole 40mg qd
    Intervention Type
    Drug
    Intervention Name(s)
    Dexlansoprazole group
    Other Intervention Name(s)
    Dexilant
    Intervention Description
    Dexlansoprazole 60mg qd
    Primary Outcome Measure Information:
    Title
    Rate of complete symptom resolution (CSR)
    Description
    Evaluate the complete symptom resolution by questionnaire
    Time Frame
    1 week after finishing study drug
    Secondary Outcome Measure Information:
    Title
    Rate of symptom relapse
    Description
    Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life
    Time Frame
    12 weeks after finishing study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited Exclusion Criteria: taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy coexistence of peptic ulcer or gastrointestinal malignancies pregnancy coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), previous gastric surgery allergy to dexlansoprazole or esomeprazole symptom score of a validated questionnaire (Chinese GERDQ) less than 12
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deng-Chyang Wu, MD, PhD
    Organizational Affiliation
    Kaohsiung Medical University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Seng-Kee Chuah, MD
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31118571
    Citation
    Chiang HH, Wu DC, Hsu PI, Kuo CH, Tai WC, Yang SC, Wu KL, Yao CC, Tsai CE, Liang CM, Wang YK, Wang JW, Huang CF, Chuah SK; Taiwan Acid-Related Disease Study Group. Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial. Drug Des Devel Ther. 2019 Apr 26;13:1347-1356. doi: 10.2147/DDDT.S193559. eCollection 2019.
    Results Reference
    derived

    Learn more about this trial

    Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B

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