Overview

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

Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
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.