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

NCT01128582 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-12

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease
  • Chronic Insomnia

Interventions

DRUG

Rozerem (ramelteon)

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

DRUG

placebo

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

Sponsors & Collaborators

  • Southern Arizona VA Health Care System

    lead FED

Principal Investigators

  • Ronnie Fass, MD · Southern Arizona Veterans Health Care System-BREFSA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128582 on ClinicalTrials.gov