GERD Gastroesophageal Reflux Disease
Conditions
Keywords
Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn
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).
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).
Interventions
DRUGOmeprazole
Sponsors
Torax Medical Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elimination of Moderate-severe Regurgitation at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 21 US clinical sites between July 2015 and February 2017
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\] | 102 |
| Treatment Arm LINX Reflux Management System | 50 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 2 |
Baseline characteristics
| Characteristic | Control Arm | Total | Treatment Arm |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13.7 | 46.9 years STANDARD_DEVIATION 13.4 | 47.8 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 144 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 93 Participants | 141 Participants | 48 Participants |
| Region of Enrollment United States | 102 participants | 152 participants | 50 participants |
| Sex: Female, Male Female | 47 Participants | 66 Participants | 19 Participants |
| Sex: Female, Male Male | 55 Participants | 86 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 50 |
| other Total, other adverse events | 10 / 102 | 24 / 50 |
| serious Total, serious adverse events | 0 / 102 | 1 / 50 |
Outcome results
Primary
Elimination of Moderate-severe Regurgitation at 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.
Time frame: 6 months
Population: Excludes three subjects (2 LINX, 1 PPI) withdrawn following randomization and prior to either the implant procedure or start of double dose PPIs. One additional LINX subject in whom an implant was aborted due to device sizing issues was also excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Elimination of Moderate-severe Regurgitation at 6 Months | 10 Participants |
| Treatment Arm | Elimination of Moderate-severe Regurgitation at 6 Months | 42 Participants |
Secondary
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
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.
Time frame: 6 months
Population: All available follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores | 7 Participants |
| Treatment Arm | Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores | 38 Participants |