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

Phase 3

• Conditions: Gastroesophageal Reflux Disease; Chronic Insomnia
• Interventions: Drug: Rozerem (ramelteon); Drug: placebo

• Registration Number: NCT01128582
• Lead Sponsor: Southern Arizona VA Health Care System

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Status Verified: 2011-03
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rozerem	Rozerem (ramelteon)	Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
placebo	placebo	Comparing the effect of Rozerem vs. placebo on GERD symptomatology

Primary Outcome Measures

Name	Time	Method
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.	4 week trial	The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

Secondary Outcome Measures

Name	Time	Method
Improving quality of sleep and quality of life.	4 week trial period	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.

Trial Locations

Locations (1)

Southern Arizona Veterans Health Care System; 🇺🇸 Tucson, Arizona, United States