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

Study Overview
=================
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.

Official Title
-----------------
Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.

Conditions
-----------------
Gastroesophageal Reflux Disease, Chronic Insomnia

Intervention / Treatment
-----------------
* Drug: Rozerem (ramelteon)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 82 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rozerem<br>Comparing the effect of Rozerem vs. placebo on GERD symptomatology. | Drug: Rozerem (ramelteon)<br>* dosage= take 1 tablet(8 MG) 20 min. before bedtime<br>* Other names: ramelteon;|
| Placebo Comparator: placebo<br>Comparing the effect of Rozerem vs. placebo on GERD symptomatology | Drug: placebo<br>* Comparing the effect of Rozerem vs. placebo on GERD symptomatology.<br>* Other names: sugar pill;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 week trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 week trial period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Insomnia, Acid Reflux, Heartburn