NCT02755753

A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: YongChan Lee · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

Detailed description

1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients 2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Lansoprazole	Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
DRUG	Rebamipide	Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
DRUG	Rebamipide-placebo	Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2016-04-29
• Last updated: 2016-04-29

Locations

5 sites across 2 countries: China, South Korea