Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

Southern Arizona VA Health Care System40 enrolled

Overview

To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.

This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease Chronic Insomnia

Interventions

Rozerem (ramelteon)DRUG

dosage= take 1 tablet(8 MG) 20 min. before bedtime

placeboDRUG

Comparing the effect of Rozerem vs. placebo on GERD symptomatology.

Eligibility

Sex: ALLMax age: 82 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stop H2 blockers 72 hrs prior to starting study * Stop PPI - 3 weeks prior to staring study * Heartburn 3+ times a week * Insomnia 3+ times a week for 3 months * Erosive esophagitis or Abnormal pH test Exclusion Criteria: * On PPI or H2 blocker \& not willing to get off * Normal EGD (upper endoscopy) w/ normal pH test * Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C\&D) LA=Los Angeles criteria. Grades include A-D * Previous gastrointestinal Surgery * HX of Diabetes/neuropathy * HX of seizures * Known psychological abnormalities(depression,anxiety...) * Clinically Significant Underlying co morbidity * Narcotic medications(pain meds) * Regularly taking sleeping medications (2 week wash-out allowed) * Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.

Locations (1)

Southern Arizona Veterans Health Care System

Tucson, Arizona, United States

Outcomes

Primary Outcomes

The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.

The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

Time frame: 4 week trial

Secondary Outcomes

Improving quality of sleep and quality of life.

It is believed that poor quality of sleep can cause more esophageal acid exposure. Thus, it is possible that treatment of insomnia may have a beneficial effect on GERD symptomatology as well as actually reduce esophageal acid reflux.

Time frame: 4 week trial period

Data from ClinicalTrials.gov

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