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Rozerem for Acid Reflux (Rozerem Trial)
Phase 3
Waitlist Available
Led By Ronnie Fass, MD
Research Sponsored by Southern Arizona VA Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week trial
Awards & highlights
Rozerem Trial 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.
Eligible Conditions
- Acid Reflux
- Chronic Insomnia
Rozerem Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 week trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
Secondary outcome measures
Improving quality of sleep and quality of life.
Rozerem Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: RozeremActive Control1 Intervention
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
Group II: placeboPlacebo Group1 Intervention
Comparing the effect of Rozerem vs. placebo on GERD symptomatology
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Who is running the clinical trial?
Southern Arizona VA Health Care SystemLead Sponsor
10 Previous Clinical Trials
868 Total Patients Enrolled
Ronnie Fass, MDPrincipal InvestigatorSouthern Arizona Veterans Health Care System-BREFSA
10 Previous Clinical Trials
379 Total Patients Enrolled
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