Overview
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Status:
Unknown status
Unknown status
Trial end date:
2011-12-01
2011-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Southern Arizona VA Health Care System
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.