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
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|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.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
- Age≥ 21 years old.
- Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.
- Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
- Patient has provided written informed consent for participation in the randomized study.
Key Exclusion Criteria:
- Currently taking double-dose PPIs (twice daily dosing).
- Hiatal hernia >3cm as determined by endoscopy.
- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
- Esophagitis Grade C or D (Los Angeles classification).
- Body mass index >35.
- Diagnosed with an esophageal motility disorder LES.
- Esophageal stricture or gross esophageal anatomic abnormalities
- History of/or known Barrett's esophagus.
- Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
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
Documents provided by Torax Medical Incorporated:
|Responsible Party:||Torax Medical Incorporated|
|Other Study ID Numbers:||
|First Posted:||July 22, 2015 Key Record Dates|
|Results First Posted:||December 12, 2018|
|Last Update Posted:||January 7, 2019|
|Last Verified:||December 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Gastric Acid Reflux Disease
Esophageal Motility Disorders
Digestive System Diseases
Proton Pump Inhibitors
Molecular Mechanisms of Pharmacological Action