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

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Esomeprazole group; Drug: Dexlansoprazole group

• Registration Number: NCT03128736
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2016-02-28
• Study Completion: 2016-03-30
• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esomeprazole group	Esomeprazole group	esomeprazole 40mg
dexlansoprazole group	Dexlansoprazole group	dexlansoprazole 60mg

Primary Outcome Measures

Name	Time	Method
Rate of complete symptom resolution (CSR)	1 week after finishing study drug	Evaluate the complete symptom resolution by questionnaire

Secondary Outcome Measures

Name	Time	Method
Rate of symptom relapse	12 weeks after finishing study drug	Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life