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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128736
• Other study ID #: KMUHIRB-2014-09-02(I)
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2017
• Last updated: April 20, 2017
• Start date: April 1, 2014
• Est. completion date: March 30, 2016

Study information

• Verified date: April 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 30, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole group
Esomeprazole 40mg qd
• Dexlansoprazole group
Dexlansoprazole 60mg qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete symptom resolution (CSR)	Evaluate the complete symptom resolution by questionnaire	1 week after finishing study drug
Secondary	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