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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rozerem

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

Group Type ACTIVE_COMPARATOR

Rozerem (ramelteon)

Intervention Type DRUG

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

placebo

Comparing the effect of Rozerem vs. placebo on GERD symptomatology

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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Rozerem (ramelteon)

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Rozerem ramelteon sugar pill

Eligibility Criteria

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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.

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No