Overview

This trial is active, not recruiting.

Conditions gastroesophageal reflux disease, chronic insomnia
Treatments rozerem (ramelteon), placebo
Phase phase 3
Sponsor Southern Arizona VA Health Care System
Start date March 2009
End date December 2011
Trial size 40 participants
Trial identifier NCT01128582, Rozerem

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
rozerem (ramelteon) Rozerem
dosage= take 1 tablet(8 MG) 20 min. before bedtime
(Placebo Comparator)
Comparing the effect of Rozerem vs. placebo on GERD symptomatology
placebo placebo
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.

Primary Outcomes

Measure
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
time frame: 4 week trial

Secondary Outcomes

Measure
Improving quality of sleep and quality of life.
time frame: 4 week trial period

Eligibility Criteria

Male or female participants up to 82 years old.

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.

Additional Information

Official title Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
Principal investigator Ronnie Fass, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Southern Arizona VA Health Care System.