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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Esomeprazole group
* Drug: Dexlansoprazole group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexlansoprazole group<br>dexlansoprazole 60mg | Drug: Dexlansoprazole group<br>* Dexlansoprazole 60mg qd<br>* Other names: Dexilant;|
| Experimental: esomeprazole group<br>esomeprazole 40mg | Drug: Esomeprazole group<br>* Esomeprazole 40mg qd<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete symptom resolution (CSR) | Evaluate the complete symptom resolution by questionnaire | 1 week after finishing study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks after finishing study drug |