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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
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
GERD Gastroesophageal Reflux Disease Drug: Omeprazole Device: LINX Reflux Management System Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Arm
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
 Drug: Omeprazole
Other Name: Prilosec
Active Comparator: Treatment Arm
LINX Reflux Management System
 Device: LINX Reflux Management System


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
  2. Age≥ 21 years old.
  3. 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.
  4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
  5. Patient has provided written informed consent for participation in the randomized study.

Key Exclusion Criteria:

  1. Currently taking double-dose PPIs (twice daily dosing).
  2. Hiatal hernia >3cm as determined by endoscopy.
  3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
  4. Esophagitis Grade C or D (Los Angeles classification).
  5. Body mass index >35.
  6. Diagnosed with an esophageal motility disorder LES.
  7. Esophageal stricture or gross esophageal anatomic abnormalities
  8. History of/or known Barrett's esophagus.
  9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Torax Medical Incorporated
  Study Documents (Full-Text)

Documents provided by Torax Medical Incorporated:
Study Protocol and Statistical Analysis Plan  [PDF] June 8, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT02505945    
Other Study ID Numbers: 4959
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
Keywords provided by Torax Medical Incorporated:
Esophageal Reflux
Gastric Acid Reflux Disease
Heartburn
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action