Back to resultsReletex for Nausea in GERD Patients
Primary Purpose
Nausea
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reletex
Sponsored by
About this trial
This is an interventional treatment trial for Nausea
Eligibility Criteria
Inclusion Criteria:
- Any patient over the age of 18 with clinically diagnosed GERD as evidenced by the GerdQ assessment tool and/or ambulatory pH/ pH- impedance monitoring with a component of nausea with or without vomiting.
- Continued symptoms despite a stable dose of FDA approved daily PPI therapy in addition to or without supportive anti-emetics. We will include patients with twice a day PPI dosing, as this is a standard treatment for PPI non-responders.
- Previous gastric emptying study performed as part of the standard care work-up of nausea and vomiting. Patients will be recruited regardless of the results and this information will only be used as a potential predictor for symptom response.
Exclusion Criteria:
- Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks.
- Prior gastrointestinal surgery of the esophagus and stomach.
- Severe esophagitis (Los Angeles esophagitis Grade C and above), Barrett's metaplasia or eosinophilic esophagitis, achalasia or spastic motor disorder
- Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. Current drug or alcohol abuse or dependency.
- Current neurologic or cognitive illness or impairment which would make the patient an unsuitable candidate for hypnosis. This will be determined by the investigators before randomization using the Mini Mental Status Exam in patients with suspected impairment.
- Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder.
- Those with nickel, gold, or other metal allergies.
- Those with other neuromodulators or implanted electrical devices such as cardiac pacemakers, AICD's, neurostimulators or transcutaneous electrical nerve stimulation devices (TENS units).
- Females who are or might become pregnant during the study.
Sites / Locations
- Northwestern Medical Faculty Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GERD subjects with nausea
Arm Description
subjects with GERD and nausea will receive treatment with Reletex
Outcomes
Primary Outcome Measures
Incidence of Nausea in Patients With GERD
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT01582100
First Posted
April 19, 2012
Last Updated
November 5, 2014
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01582100
Brief Title
Reletex for Nausea in GERD Patients
Official Title
Reletex ™ Band as an Adjunct to Standard Therapy in Patients With GERD, Nausea With or Without Vomiting- A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
study was terminated by investigator due to low enrollment
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently encountered in the health care setting. It affects roughly 40% of Americans monthly and 10% weekly. Of those with GERD, there exists a cohort that experience nausea with or without vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment options are limited and these symptoms may substantially alter their quality of life. New and novel therapies emerging include neuromodulation devices that may affect the central pathways leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery, in addition to standard anti-nausea medications. The investigators propose that through a similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of lives in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GERD subjects with nausea
Arm Type
Experimental
Arm Description
subjects with GERD and nausea will receive treatment with Reletex
Intervention Type
Device
Intervention Name(s)
Reletex
Intervention Description
Neuromodulation device worn on the wrist
Primary Outcome Measure Information:
Title
Incidence of Nausea in Patients With GERD
Description
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient over the age of 18 with clinically diagnosed GERD as evidenced by the GerdQ assessment tool and/or ambulatory pH/ pH- impedance monitoring with a component of nausea with or without vomiting.
Continued symptoms despite a stable dose of FDA approved daily PPI therapy in addition to or without supportive anti-emetics. We will include patients with twice a day PPI dosing, as this is a standard treatment for PPI non-responders.
Previous gastric emptying study performed as part of the standard care work-up of nausea and vomiting. Patients will be recruited regardless of the results and this information will only be used as a potential predictor for symptom response.
Exclusion Criteria:
Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks.
Prior gastrointestinal surgery of the esophagus and stomach.
Severe esophagitis (Los Angeles esophagitis Grade C and above), Barrett's metaplasia or eosinophilic esophagitis, achalasia or spastic motor disorder
Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. Current drug or alcohol abuse or dependency.
Current neurologic or cognitive illness or impairment which would make the patient an unsuitable candidate for hypnosis. This will be determined by the investigators before randomization using the Mini Mental Status Exam in patients with suspected impairment.
Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder.
Those with nickel, gold, or other metal allergies.
Those with other neuromodulators or implanted electrical devices such as cardiac pacemakers, AICD's, neurostimulators or transcutaneous electrical nerve stimulation devices (TENS units).
Females who are or might become pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Pandolfino, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reletex for Nausea in GERD Patients
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