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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2016-03-30

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.

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexlansoprazole group

dexlansoprazole 60mg

Group Type EXPERIMENTAL

Dexlansoprazole group

Intervention Type DRUG

Dexlansoprazole 60mg qd

esomeprazole group

esomeprazole 40mg

Group Type EXPERIMENTAL

Esomeprazole group

Intervention Type DRUG

Esomeprazole 40mg qd

Interventions

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Esomeprazole group

Esomeprazole 40mg qd

Intervention Type DRUG

Dexlansoprazole group

Dexlansoprazole 60mg qd

Intervention Type DRUG

Other Intervention Names

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Nexium Dexilant

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No