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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease, Chronic Insomnia

In brief

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.

Key facts

Study ID

NCT01128582

Run by

Southern Arizona VA Health Care System

People needed

40

Starts

2009-03-01

Expected to finish

2011-12-01

Last updated by the study team

2011-05-12

Who can join

Age: any, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Southern Arizona Veterans Health Care System — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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