Reletex for Nausea in GERD Patients

Nausea Clinical Trial

Official title:

Reletex ™ Band as an Adjunct to Standard Therapy in Patients With GERD, Nausea With or Without Vomiting- A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01582100
• Other study ID #: 56024
• Status: Terminated
• Phase: N/A
• First received: April 19, 2012
• Last updated: November 5, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea

Intervention

Device:
• Reletex
Neuromodulation device worn on the wrist

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nausea in Patients With GERD	number of events of nausea with or without vomiting in patients with GERD in 4 weeks	4 weeks	No