Clinical trial NCT03128736: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of complete symptom resolution (CSR)
timeFrame: 1 week after finishing study drug
Secondary outcomes:
measure: Rate of symptom relapse
timeFrame: 12 weeks after finishing study drug
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University
name: Deng-Chyang Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Seng-Kee Chuah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.