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

Kaohsiung Medical University

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Dexlansoprazole group; Drug: Esomeprazole group

Study type: Interventional

Funder types: Other

Identifiers

NCT03128736

KMUHIRB-2014-09-02(I)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups

dexlansoprazole group

Experimental group

Description:

dexlansoprazole 60mg

Treatment:

Drug: Dexlansoprazole group

esomeprazole group

Experimental group

Description:

esomeprazole 40mg

Treatment:

Drug: Esomeprazole group