Dexlansoprazole MR in Nonerosive Reflux Disease

Nonerosive Reflux Disease Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02490449
• Other study ID #: SCHBC 2014-05-021-002
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 13, 2014
• Last updated: July 2, 2015
• Start date: December 2014

Study information

• Verified date: July 2015
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 356
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• NERD confirmed by gastroscopy

Exclusion Criteria:

• PPI medication within 2 weeks before enrollment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Nonerosive Reflux Disease

Intervention

Drug:
• Dexlansoprazole MR
Administration of drug after or before diet

Locations

Country	Name	City	State
Korea, Republic of	Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of patients free of reflux symptoms		4 weeks	Yes