NCT02505945

The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Torax Medical Incorporated · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).

Detailed description

Prospective, multicenter, 2:1 randomized, cross-over, two arms * Control arm: Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\] * Treatment arm: LINX Reflux Management System Up to 20 study centers throughout the U.S. will participate. Approximately150 patients will be enrolled into the study. Subjects will be randomized 2:1 into the double-dose PPIs arm (100 subjects) and the LINX arm (50 subjects).

Conditions

• GERD Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Omeprazole
DEVICE	LINX Reflux Management System

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-10-01
• Completion: 2018-08-01
• First posted: 2015-07-22
• Last updated: 2019-01-07
• Results posted: 2018-12-12

Locations

21 sites across 1 country: United States