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

Southern Arizona VA Health Care System

Status and phase

Unknown

Phase 3

Conditions

Chronic Insomnia

Gastroesophageal Reflux Disease

Treatments

Drug: Rozerem (ramelteon)

Drug: placebo

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01128582

Rozerem

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 82 years old

Volunteers

No Healthy Volunteers

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.