Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B
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
1 other identifier
interventional
175
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2016
CompletedFirst Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedApril 25, 2017
April 1, 2017
1.9 years
April 20, 2017
April 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of complete symptom resolution (CSR)
Evaluate the complete symptom resolution by questionnaire
1 week after finishing study drug
Secondary Outcomes (1)
Rate of symptom relapse
12 weeks after finishing study drug
Study Arms (2)
dexlansoprazole group
EXPERIMENTALdexlansoprazole 60mg
esomeprazole group
EXPERIMENTALesomeprazole 40mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31118571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deng-Chyang Wu, MD, PhD
Kaohsiung Medical University
- PRINCIPAL INVESTIGATOR
Seng-Kee Chuah, MD
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 25, 2017
Study Start
April 1, 2014
Primary Completion
February 28, 2016
Study Completion
March 30, 2016
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share