The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease (CALIBER)
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|ClinicalTrials.gov Identifier: NCT02505945|
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : December 12, 2018
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|GERD Gastroesophageal Reflux Disease||Drug: Omeprazole Device: LINX Reflux Management System||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||August 2018|
Active Comparator: Control Arm
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
Other Name: Prilosec
Active Comparator: Treatment Arm
LINX Reflux Management System
Device: LINX Reflux Management System
- Elimination of Moderate-severe Regurgitation at 6 Months [ Time Frame: 6 months ]The primary endpoint was the percent of patients in both treatment arms who achieved elimination of moderate-severe regurgitation at 6 months, as reported on the foregut symptom questionnaire.
- Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores [ Time Frame: 6 months ]Successful Reduction at 6 months (≥50% reduction in total) Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores from Baseline PPI On medication GERD HRQL scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505945