Reletex for Nausea in GERD Patients

NCT01582100 | Terminated Results

• 1 other identifier: 56024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GERD subjects with nausea

EXPERIMENTAL

subjects with GERD and nausea will receive treatment with Reletex

Device: Reletex

Interventions

Reletex DEVICE

Neuromodulation device worn on the wrist

GERD subjects with nausea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated due to low enrollment. One subject withdrew due to minor wrist discomfort and the other withdrew after determining the study schedule was undesirable.

Results Point of Contact

• Title: Christine Ebert Nelson
• Organization: Northwestern University

c-ebert@northwestern.edu

3126954513

Study Officials

• John E Pandolfino, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 13, 2014
• Results First Posted: November 13, 2014

Record last verified: 2014-07

Locations

US (1)